A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects

Start Date25 Mar 2025

Sponsor / Collaborator

Celltrion, Inc.

NCT04817540

/ RecruitingPhase 2IIT

Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)

In this study, we prospectively analyzed molecular subtyping through the PAM 50 test in HER2-negative (IHC1+ or 2+ (FISH/SISH-)) breast cancer patients. A phase 2 single arm study was designed to determine whether the addition of HER2-targeted treatment with treatment increases the pathologic remission rate.

Start Date01 Sep 2021

Sponsor / Collaborator

Gangnam Severance Hospital

NCT06907082

/ CompletedNot ApplicableIIT

Prospective Multicenter Observational Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Based on Dual Blockade With Pertuzumab and the Trastuzumab Biosimilar CT-P6 (Herzuma®) in Early HER2-positive Breast Cancer in Routine Clinical Practice

The study hypothesis is to evaluate whether the pCR rate of neoadjuvant chemotherapy and dual blockade with pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in HER2-positive early breast cancer in PCH is similar to that reported in clinical trials.
Other aspects to be analyzed include the safety of the combination in PCH, as well as the clinical and tumor characteristics of the study population, assessment of radiological and pathological response, and the role of treatment-induced immunogenicity and the value of plasma HER2 determination.

Start Date28 Dec 2020

Sponsor / Collaborator-

100 Clinical Results associated with Trastuzumab-PKRB(Celltrion)

100 Translational Medicine associated with Trastuzumab-PKRB(Celltrion)

100 Patents (Medical) associated with Trastuzumab-PKRB(Celltrion)

Literatures (Medical) associated with Trastuzumab-PKRB(Celltrion)

01 Apr 2025·JCO Precision Oncology

Safety and Efficacy of Anti–Human Epidermal Growth Factor 2 Agents in the Treatment of Biliary Tract Cancers: A Systematic Review

Review

Author: Chakrabarti, Sakti ; Mahipal, Amit ; Jin, Zhaohui ; Pawar, Omkar ; Mangla, Ankit ; Naleid, Nikolas

PURPOSE:

Limited treatment options exist for patients with locally advanced or metastatic biliary tract cancers (BTCs). Recently, several clinical trials provided preliminary evidence for human epidermal growth factor receptor 2 (HER2) as a new target for patients with HER2-expressing BTC. We conducted a systematic review and pooled analysis of the safety and efficacy of anti-HER2 agents in patients with advanced BTCs.

METHODS:

A comprehensive search of PubMed/MEDLINE and EMBASE was performed to identify phase I, II, or III clinical trials published between January 2019 and March 2024 that evaluated anti-HER2 therapy in locally advanced or metastatic BTC. Participant data included in the analysis were from trials evaluating the efficacy and safety of various anti-HER2 agents. The primary end points included objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). The secondary end points included incidence of treatment-related adverse events (TRAEs), rate of treatment discontinuation, and death.

RESULTS:

The analysis included 368 patients from eight publications diagnosed with advanced BTC. Patients were treated with several anti-HER2 agents including zanidatamab, pertuzumab plus trastuzumab, tucatinib plus trastuzumab, trastuzumab deruxtecan, trastuzumab plus chemotherapy, trastuzumab-pkrb plus chemotherapy, and neratinib. The pooled ORR and DCR were 34% (95% CI, 24 to 44) and 64% (95% CI, 51 to 77), respectively. The pooled weighted PFS and median overall survival were 4.8 and 9.4 months, respectively. The pooled duration of response for the reporting trials was 5.0 months. In the study cohort, 82.6% of patients experienced any adverse event and 32.1% experienced a grade 3-4 adverse event. Only 5.7% of the patients discontinued treatment secondary to TRAEs.

CONCLUSION:

In patients with HER2-expressing BTCs, anti-HER2 therapies are viable options, particularly in the second-line setting.

01 Feb 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Challenges with effective removal of surfactants from monoclonal antibody formulations

Article

Author: Suryanarayanan, Raj ; Nejadnik, Reza ; Gurvich, Vadim J ; Refaat, Hesham ; Rathore, Anurag S ; Ahmad, Aziz ; Kamel, Eman

Buffer exchange is a critical step in biologics development, playing a pivotal role in removing contaminants, adjusting sample conditions, and facilitating compatibility studies. The efficiency of centrifugal concentrators for polysorbate removal was compared to a two-step approach involving a surfactant removal column followed by buffer exchange. Trastuzumab-pkrb from Herzuma® was used. While a 30 kDa centrifugal concentrator was ineffective in polysorbate removal, a 50 kDa concentrator caused partial removal. Surfactant removal column proved more effective in removing polysorbates. Buffer exchange using polysorbate-containing formulation buffer, even with a 50 kDa concentrator, accumulated polysorbate, revealing the need for a different approach in small-scale formulation. Adding polysorbate in a separate step after buffer exchange appeared to be a good strategy to prevent this problem. The two approaches did not reveal any differences in the protein aggregation behavior.

01 Oct 2023·Cancer

A phase 2 multicenter study of docetaxel-PM and trastuzumab-pkrb combination therapy in recurrent or metastatic salivary gland carcinomas.

Article

Author: Shim, Byoung-Yong ; Park, Sehhoon ; Kim, Sung-Bae ; Shin, Seong Hoon ; Seo, Seyoung ; Kim, Ji-Won ; An, Ho-Jung ; Kim, Min Kyoung ; Kim, Ju Won ; Ahn, Myung-Ju ; Choi, Yoon Ji ; Oh, So Yeon ; Park, Lee Chun ; Kim, Jae-Joon ; Lee, Se-Hoon ; Lee, Keun-Wook ; Jung, Hyun Ae ; Lee, Jiyun ; Kang, Eun Joo

BACKGROUND:

Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. The high positivity rate for human epidermal growth factor receptor 2 (HER2) led to an investigation of the efficacy of HER2-targeted agents. Docetaxel-PM (polymeric micelle) is a low-molecular-weight, nontoxic, biodegradable, and docetaxel-loaded micellar formulation. Trastuzumab-pkrb is a biosimilar to trastuzumab.

METHODS:

This was a multicenter, single-arm, open-label phase 2 study. Patients with HER2-positive (immunohistochemistry [IHC] score of ≥2+ and/or HER2/chromosome enumeration probe 17 [CEP17] ratio of ≥2.0) advanced SDCs were enrolled. Patients received docetaxel-PM (75 mg/m² ) and trastuzumab-pkrb (8 mg/kg in the first cycle and 6 mg/kg in subsequent cycles) every 3 weeks. Primary end point was objective response rate (ORR).

RESULTS:

A total of 43 patients were enrolled. The best objective responses were partial response in 30 (69.8%) patients and stable disease in 10 (23.3%) patients, leading to an ORR of 69.8% (95% confidence interval [CI], 53.9-82.8) and a disease control rate of 93.0% (80.9-98.5). Median progression-free survival, duration of response, and overall survival were 7.9 (6.3-9.5), 6.7 (5.1-8.4), and 23.3 (19.9-26.7) months, respectively. Patients with HER2 IHC score of 3+ or HER2/CEP17 ratio ≥2.0 demonstrated better efficacies compared to those with HER2 IHC score of 2+. Thirty-eight (88.4%) patients experienced treatment-related adverse events (TRAE). Because of TRAE, nine (20.9%), 14 (32.6%), and 19 (44.2%) patients required temporary discontinuation, permanent discontinuation, or dose reduction, respectively.

CONCLUSIONS:

The combination of docetaxel-PM and trastuzumab-pkrb demonstrated promising antitumor activity with a manageable toxicity profile in HER2-positive advanced SDC.

PLAIN LANGUAGE SUMMARY:

Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. SDC shares morphological and histological similarities with invasive ductal carcinoma of breast, which led to an investigation of hormonal receptor and human epidermal growth factor receptor 2 (HER2)/neu expression status in SDC. In this study, patients with HER2-positive SDC were enrolled and treated with combination of docetaxel-polymeric micelle and trastuzumab-pkrb. Promising antitumor activities were shown with objective response rate of 69.8%, disease control rate of 93.0%, median progression-free survival of 7.9 months, median duration of response of 6.7 months, and median overall survival of 23.3 months.

News (Medical) associated with Trastuzumab-PKRB(Celltrion)

08 Jul 2025

·www.prnewswire.com

Amid NCI Budget Fears, Emerging Oncology Stocks Gain Attention

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 8, 2025 /PRNewswire/ -- Equity Insider News Commentary – As cancer rates climb and drug costs continue to soar, pressure is mounting on the private sector to drive innovation. Now, cancer experts are alarmed over a "gut wrenching" plan from the U.S. government to cut nearly 40% of National Cancer Institute funding, even as the price of oncology treatments pushes new limits—raising urgent concerns about access and affordability. In this shifting landscape, investors are turning their attention to a new wave of biotechs and specialty care providers developing breakthrough therapies and smarter care models, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Citius Oncology, Inc. (NASDQ: CTOR), Exelixis, Inc. (NASAQ: EXEL), and The Oncology Institute, Inc. (NASDAQ: TOI). Continue Reading Amid NCI Budget Fears, Emerging Oncology Stocks Gain Attention Market forecasts suggest oncology could be one of the decade's fastest-growing sectors. Nova One Advisor projects the global oncology drug market will reach US$366.24 billion by 2034, with a 7.4% CAGR. Other firms are even more bullish— ResearchAndMarkets sees the market hitting US$866.1 billion, while Vision Research Reports expects revenue in 2034 to surpass US$903.81 billion, fueled by rising demand for advanced diagnostics and targeted therapies. For emerging cancer stocks, the timing couldn't be better. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has highlighted survival data that may redefine expectations for immunotherapy in cold tumors, especially in metastatic pancreatic and breast cancers, where treatment options remain limited. In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), Oncolytics's flagship pelareorep, an intravenously delivered immunotherapeutic agent, has a two-year overall survival rate of 21.9% across pooled data from more than 100 patients—more than double the historical benchmark of 9.2%. "We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, newly-appointed CEO of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology." In a single-arm study combining pelareorep with chemotherapy and a checkpoint inhibitor, the objective response rate reached 62% in evaluable patients. No immunotherapy is currently approved in first-line metastatic pancreatic ductal adenocarcinoma. Breast cancer results are also very impressive. In HR+/HER2- metastatic breast cancer (mBC), pelareorep extended median overall survival by more than 10 months across two randomized trials compared to standard chemotherapy. In the BRACELET-1 trial, pelareorep plus paclitaxel delivered median progression-free survival of 12.1 months—nearly doubling the 6.4 months observed in the control arm. "Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies." With over 1,100 patients studied to date, pelareorep continues to demonstrate a favorable safety profile, with most side effects limited to transient, flu-like symptoms. The company says it is now preparing for registration-enabling trials, leveraging its existing Fast Track designations in both mPDAC and HR+/HER2- mBC, as well as Orphan Drug status for pancreatic cancer in both the U.S. and Europe. The company recently reinforced its leadership bench with two high-profile appointments—naming Jared Kelly as Chief Executive Officer and Andrew Aromando as Chief Business Officer—as the company sharpens its focus on late-stage development and strategic transactions. Both men previously played key roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson and bring a track record of value creation in oncology-focused biotechs. Their arrival signals a deliberate pivot toward unlocking the value of pelareorep, Oncolytics' virus-based immunotherapy currently in multiple mid-to-late-stage studies. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said CEO Jared Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC), and has shown encouraging synergy with checkpoint inhibitors and chemotherapy. In mPDAC, Phase 2 data showed objective response rates above 60% in tumor-evaluable patients, exceeding historical benchmarks, with survival at two years also outperforming expectations. Meanwhile, in HR+/HER2- mBC, two randomized phase 2 trials (IND-213 and BRACELET-1) demonstrated overall survival trends that support continued development. The drug's potential may extend even further. A Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor produced responses that surpassed historical checkpoint monotherapy outcomes, suggesting broader utility. Most recently, new data from the GOBLET trial presented at ASCO 2025 highlighted pelareorep's ability to activate both innate and adaptive immune responses in metastatic pancreatic cancer—reinforcing its potential as a backbone immunotherapy. With experienced leadership now in place and a growing clinical footprint, Oncolytics is advancing toward potential partnership, planning registration-enabling trials, and commercialization readiness—all while maintaining a disciplined, investor-aligned approach to capital and growth. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) has reported encouraging early-phase data from two separate clinical trials evaluating gedatolisib in prostate and breast cancer. In metastatic castration-resistant prostate cancer, a Phase 1 trial combining gedatolisib with darolutamide showed a 66% six-month radiographic progression-free survival rate. "We are very encouraged by this preliminary efficacy and safety data," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "The 66% six-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. With no treatment-related discontinuations and less than 3% of patients experiencing Grade 3 stomatitis, we believe it is important to explore additional dose options for gedatolisib." In HER2+ metastatic breast cancer, a Phase 2 trial of gedatolisib plus standard doses of trastuzumab-pkrb showed a 43% objective response rate in patients who had received at least three prior lines of therapy. Citius Oncology, Inc. (NASDQ: CTOR) is preparing to launch LYMPHIR, an FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma, in the second half of 2025. "We've made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community." The company has completed commercial-scale manufacturing, secured distribution partnerships, and built a launch strategy with AI-enhanced targeting of key oncology centers. With regulatory infrastructure in place and early clinical interest, Citius is positioned to transition into full commercial operations this year. Exelixis, Inc. (NASAQ: EXEL) reported positive Phase 3 results from its STELLAR-303 trial, showing that zanzalintinib combined with atezolizumab significantly improved overall survival versus regorafenib in patients with metastatic colorectal cancer. "The STELLAR-303 results, which showed a survival benefit with the combination of zanzalintinib and atezolizumab versus regorafenib across all randomized patients with previously treated metastatic colorectal cancer, marks an important first milestone for our zanzalintinib pivotal development program," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing the findings with regulatory authorities and presenting the detailed results at an upcoming medical conference." The combination met one of the trial's dual primary endpoints, and a final analysis for the second—overall survival in patients without liver metastases—is still pending. No new safety signals were observed, and full results are expected at an upcoming medical conference. The Oncology Institute, Inc. (NASDAQ: TOI) has entered into a major partnership with SilverSummit Healthplan to provide oncology care to over 80,000 Medicaid members across Nevada. "We couldn't be more excited about the opportunity to expand our partnership with SilverSummit and help create improved access and quality of cancer care to their Medicaid patient population," said Daniel Virnich, MD, CEO of The Oncology Institute. "We have a longstanding track record of providing outstanding care to Medicaid patients in other markets, and we look forward to broadening these efforts within the Las Vegas community." Effective July 1, TOI is now the exclusive provider of cancer services for SilverSummit's patient base, with dedicated clinics already open in Las Vegas, Henderson, and Spring Valley. The expansion reflects TOI's ongoing growth in value-based oncology, particularly among underserved populations. Both organizations emphasized the importance of delivering high-quality, community-based cancer care tailored to the needs of Medicaid patients. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Video - Logo - SOURCE Equity Insider WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyFast TrackPhase 2Phase 1

08 Jul 2025

·pipelinereview.com

Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)

JERSEY CITY, NJ, USA I July 7, 2025 I Celltrion USA today announced that STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo), biosimilars referencing PROLIA ® (denosumab) and XGEVA ® (denosumab) respectively, are commercially available in the United States. STOBOCLO is available in 60 mg/mL injection and is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. [1] OSENVELT is available in 120 mg/1.7 mL (70 mg/mL) injection and is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. [2] “We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems.” STOBOCLO and OSENVELT are supported by Celltrion’s comprehensive patient support programs designed to help empower patients to navigate their treatment journeys. Celltrion offers a suite of resources, including the Celltrion CONNECT ® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. Visit www.CelltrionConnect.com and www.CelltrionCares.com to learn more. Celltrion’s biosimilars portfolio covers the areas of immunology, oncology, gastroenterology, allergy, and endocrinology. About STOBOCLO ® (denosumab-bmwo) STOBOCLO ® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA ® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO ® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: For more information, see Full Prescribing Information . About OSENVELT ® (denosumab-bmwo) OSENVELT ® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA ® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT ® (denosumab-bmwo) is indicated for: For more information, see Full Prescribing Information . About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-u s and stay updated with our latest news and events on our social media – LinkedIn , Instagram , X , and Facebook . About Celltrion USA Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), AVTOZMA ® (tocilizumab-anho), STEQEYMA ® (Ustekinumab-stba) STOBOCLO ® (denosumab-bmwo), OSENVELT ® (denosumab-bmwo), and OMLYCLO ® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media – LinkedIn . [1] STOBOCLO U.S. prescribing information (2025) [2] OSENVELT U.S. prescribing information (2025) US-CT-P41-25-00006 SOURCE: Celltrion

Drug Approval

08 Jul 2025

·www.celltrion.com

Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1],[2] STOBOCLO and OSENVELT, among the first wave of biosimilars referencing PROLIA and XGEVA respectively, are commercially available in the U.S. Celltrion further expands its portfolio, delivering cost-effective and high-quality biologic medicines to wider range of patients in the U.S. Celltrion further expands its portfolio, delivering cost-effective and high-quality biologic medicines to wider range of patients in the U.S. JERSEY CITY, N.J., July 7, 2025 -- Celltrion USA today announced that STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively, are commercially available in the United States. STOBOCLO is available in 60 mg/mL injection and is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.[1] OSENVELT is available in 120 mg/1.7 mL (70 mg/mL) injection and is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.[2] "We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems." STOBOCLO and OSENVELT are supported by Celltrion's comprehensive patient support programs designed to help empower patients to navigate their treatment journeys. Celltrion offers a suite of resources, including the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. Visit www.CelltrionConnect.com and www.CelltrionCares.com to learn more. Celltrion's biosimilars portfolio covers the areas of immunology, oncology, gastroenterology, allergy, and endocrinology. About STOBOCLO® (denosumab-bmwo) STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity: If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information. About OSENVELT® (denosumab-bmwo) OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. For more information, see Full Prescribing Information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media - LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, Inc. PROLIA® and XGEVA® are registered trademarks of Amgen Inc. References [1] STOBOCLO U.S. prescribing information (2025) [2] OSENVELT U.S. prescribing information (2025) US-CT-P41-25-00006

Drug ApprovalClinical Result

100 Deals associated with Trastuzumab-PKRB(Celltrion)

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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Nippon Kayaku Co., Ltd.	01 Oct 2023
Stomach Cancer	Canada	Celltrion Healthcare Co., Ltd.	01 Sep 2019
Advanced HER2-Positive Breast Carcinoma	Australia	Celltrion Healthcare Australia Pty Ltd.	17 Jul 2018
HER2 Positive Breast Cancer	Australia	Celltrion Healthcare Australia Pty Ltd.	17 Jul 2018
HER2 positive Gastroesophageal Junction Adenocarcinoma	Australia	Celltrion Healthcare Australia Pty Ltd.	17 Jul 2018
Early Stage Breast Carcinoma	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	Norway	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2 Positive Stomach Adenocarcinoma	Norway	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	Norway	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	European Union	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	Iceland	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	Liechtenstein	Celltrion Healthcare Hungary Kft	09 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	United States	Celltrion, Inc.	10 Jun 2018
Neoplasm Metastasis	Phase 2	United States	Celltrion, Inc.	10 Jun 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01084876 (Compare, CTgov)	Phase 3	Metastatic breast cancer	475	CT-P6 (CT-P6)	dcfgpforbo = cidgeiqyvp lzurgzytwp (elhrxcwype, jfduhcqjhv - okktpryvzv) View more	-	11 Feb 2025
				Herceptin (Herceptin)	dcfgpforbo = dwenfgqvfi lzurgzytwp (elhrxcwype, zgstuwrlwz - awtrnimvaa) View more
NCT01084863 (Compare, CTgov)	Phase 1/2	Metastatic breast cancer	143	Paclitaxel+CT-P6 (CT-P6 & Paclitaxel)	mwawbtcbwa(vtdvtouurd) = bbiqasuqlf jnjfcawdoj (rifqkienam, 15000) View more	-	24 Jan 2025
				Herceptin+Paclitaxel (Herceptin & Paclitaxel)	mwawbtcbwa(vtdvtouurd) = snldfwvpqx jnjfcawdoj (rifqkienam, 9820) View more
ASCO2023	Not Applicable	BREAST CANCER, EARLY-ONSET \| Breast Cancer \| Metastatic Gastric Carcinoma	642	CT-P6	kdnccsxbuv(gguwiivgge) = veeqwhgxow quoojudliv (mqfxmtcicd )	Positive	31 May 2023
NCT03755141 (KCSG BR 18-14/KM10B, Pubmed) Manual	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	128	treatment of physician's choice +Herzuma	ekygbdsulf(zowrbvemlc) = sffsjjebwr nsnqbqsupb (bcigjrpuya, 2.8 - 7.2) View more	Positive	17 Aug 2022
NCT03614364 (KCSG HN18-08/KM11, ASCO2022) Manual	Phase 2	Salivary duct carcinoma HER2 Positive	43	Nanoxel+Herzuma	ptzrkkhrif(ghglkfojgv) = kjpfilbjvn jwhwzaxvsl (ubwebnriyh, 52 - 81) Met View more	Positive	02 Jun 2022
NCT02162667 (Pubmed \| Breast Cancer Res Treat)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant human epidermal growth factor receptor-2 (HER2)-positive	-	CT-P6	jhbqhpbliq(fcvcojdcyv): HR = 1.23 (95% CI, 0.78 - 1.93) View more	-	01 Aug 2021
				Trastuzumab
NCT02162667 (Phase III trial comparing neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer, CTgov)	Phase 3	HER2 Positive Breast Cancer	562	Trastuzumab	rvewsohslx = evgwqzsexa qjivihtqpd (uagrxuftpi, rvmegomuzx - yupbvuqrym) View more	-	29 Oct 2019
NCT02162667 (Pubmed \| Cancer Chemother Pharmacol)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant	562	CT-P6	efzggrgwwd(qtcmymzooz) = tnurhlkbai ykcrcinxhg (xucpcuezge )	Positive	01 Oct 2019
				Trastuzumab	efzggrgwwd(qtcmymzooz) = fozizuddlq ykcrcinxhg (xucpcuezge )
NCT02162667 (Phase III trial comparing neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer, SABCS2019)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant HER2 positive	549	CT-P6	eittdfiphc(lqnprshmye) = lhimxsivtp mahraolrbm (zsyzrtilhc, 80% - 90%) View more	Positive	15 Feb 2019
				Reference Trastuzumab (RTZ)	eittdfiphc(lqnprshmye) = etcprbdtsb mahraolrbm (zsyzrtilhc, 85% - 93%) View more
NCT02162667 (SABCS2018)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant HER2 positive	549	CT-P6	qbbbwjzstz(kmbshutuqr) = Grade 3 of Adams-Stokes syndrome occurring 5 months after the completion of 1-year treatment ffamunvmso (hwwyxyctbc ) View more	Positive	15 Feb 2018
				Reference Trastuzumab

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