A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara® in patients with Moderate-to-Severe Plaque Psoriasis.

Start Date09 Nov 2020

Sponsor / Collaborator

bioeq GmbH

100 Clinical Results associated with Ustekinumab-Aauz

100 Translational Medicine associated with Ustekinumab-Aauz

100 Patents (Medical) associated with Ustekinumab-Aauz

Literatures (Medical) associated with Ustekinumab-Aauz

01 May 2025·ADVANCES IN THERAPY

A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis

Article

Author: Freudensprung, Brigitte ; Nopora, Katrin ; Balser, Sigrid ; Trieb, Michael ; Papp, Kim ; Rewerski, Piotr

INTRODUCTION:

Biosimilars allow more patients access to affordable treatment options and help reduce the financial burden on healthcare systems. This multicentre trial compared the efficacy, safety, and immunogenicity of the approved biosimilar ustekinumab FYB202 with reference ustekinumab.

METHODS:

Eligible patients were ≥ 18 years old with stable moderate-to-severe plaque psoriasis for ≥ 6 months and inadequate treatment response to or intolerance of ≥ 1 previous systemic treatment. Patients were randomised (1:1) to double-blind treatment with FYB202 or reference ustekinumab; patients in the reference group who achieved Psoriasis Area and Severity Index (PASI) 75 percent improvement at week 28 were re-randomised to FYB202 or reference product. The primary efficacy endpoint was percent improvement in PASI score from baseline to week 12. Therapeutic equivalence was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 95% and 90% confidence intervals (CIs) were within the pre-defined equivalence intervals of ± 11% and ± 10%, respectively.

RESULTS:

A total of 392 patients were randomised to FYB202 (n = 197) or reference ustekinumab (n = 195). Baseline characteristics were well balanced between groups. Mean percent improvement in PASI score at week 12 was equivalent between FYB202 and reference ustekinumab with an estimated least-squares mean treatment difference of 3.27% and the two-sided 95% (- 0.90%, 7.44%) and 90% (- 0.22%, 6.77%) CIs fully contained within the pre-defined equivalence margins. Safety and immunogenicity profiles were comparable between groups. Switching from reference product to FYB202 had no clinically relevant effect on efficacy, safety, or immunogenicity.

CONCLUSION:

FYB202 demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

TRIAL REGISTRATION:

NCT04595409; EudraCT 2019-004364-21.

01 Dec 2024·Clinical Pharmacology in Drug Development

New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects

Article

Author: Wedemeyer, Ralph‐Steven ; Anschütz, Maria ; Nopora, Katrin ; Balser, Sigrid ; Schug, Barbara ; Körner, Juliane

Abstract:

In the RUSTIC trial, pharmacokinetic (PK) similarity between the proposed ustekinumab biosimilar FYB202 and EU‐approved (EU‐Ref) and US‐licensed ustekinumab (US‐Ref) as well as between both reference drugs was assessed after a single 45‐mg subcutaneous injection. Safety analyses comprised immunogenicity (antidrug antibodies, neutralizing antibodies), adverse events, and local tolerability. Overall, 491 healthy adults were randomized 1:1:1 and observed for up to 112 days; 486 completed the trial, and 478 were included in the PK analysis. All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration‐time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%‐125%. No clinically meaningful differences regarding overall safety, immunogenicity, and local tolerability were observed. Notably, after FYB202 administration, in fewer subjects at least 1 positive antidrug antibody result was observed compared to the reference groups (FYB202, 20%; EU‐Ref, 42%; US‐Ref, 51%). In conclusion, the RUSTIC trial demonstrated equivalent PK characteristics for FYB202 when compared to both EU‐Ref and US‐Ref ustekinumab and between both reference drugs. It provides the basis for the marketing authorization of FYB202, together with an extensive analytical characterization and the results of a confirmatory efficacy and safety trial in patients with moderate to severe plaque psoriasis.

01 Nov 2011·mAbsQ2 · MEDICINE

Discovery and mechanism of ustekinumab

Q2 · MEDICINE

Review

Author: Jill M. Giles-Komar ; David Peritt ; Jacqueline M. Benson ; Mary Ann Mascelli ; George A. Heavner ; David J. Shealy ; Bernard J. Scallon

Monoclonal antibody (mAb) therapy was first established upon the approval of a mouse antibody for treatment of human acute organ rejection. However, the high incidence of immune response against the mouse mAb restricted therapeutic utility. Development of chimeric, "humanized" and human mAbs broadened therapeutic application to immune-mediated diseases requiring long-term treatment. Indeed, mAb therapeutics targeting soluble cytokines are highly effective in numerous immune-mediated disorders. A recent example is ustekinumab, a first-in-class therapeutic human immunoglobulin G1 kappa mAb that binds to the interleukins (IL)-12 and IL-23, cytokines that modulate lymphocyte function, including T-helper (Th) 1 and Th17 cell subsets. Ustekinumab was generated via recombinant human IL-12 immunization of human immunoglobulin (hu-Ig) transgenic mice. Ustekinumab binds to the p40 subunit common to IL-12 and IL-23 and prevents their interaction with the IL-12 receptor β1 subunit of the IL-12 and IL-23 receptor complexes. Ustekinumab is approved for treatment of moderate-to-severe plaque psoriasis and has demonstrated efficacy in Crohn disease and psoriatic arthritis. The clinical characterization of ustekinumab continues to clarify our understanding of human immune pathologies and may offer a novel therapeutic option for certain immune-mediated diseases.

News (Medical) associated with Ustekinumab-Aauz

04 Dec 2025

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Formycon and MS Pharma sign exclusive commercialization partnership for Keytruda® biosimilar candidate FYB206 for the MENA Region

PLANEGG-MARTINSRIED, Germany and AMMAN, Jordan, Dec. 4, 2025 /PRNewswire/ -- Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon's biosimilar candidate to the blockbuster drug Keytruda®[1] (pembrolizumab), in the Middle East and North Africa ("MENA region"). The agreement includes an option for future technology transfer. Continue Reading Formycon Logo "This licensing deal for the MENA region represents the start of the commercial partnering activities for our Keytruda® biosimilar candidate. Further agreements for additional regions and countries shall follow in due time. With MS Pharma, we are leveraging the well-established excellent collaboration that has already been successfully implemented for our biosimilars FYB201, FYB202, and FYB203. MS Pharma is a strong player that can sustainably improve access to this important cancer drug across the MENA region. FYB206 is currently approaching the end of its clinical development phase, and we expect results for the primary endpoint in the first quarter of 2026," said Nicola Mikulcik, CBO of Formycon AG. "Extending our partnership with Formycon for FYB206 (pembrolizumab), is a strategically important milestone for MS Pharma. This collaboration not only strengthens our position as a leader in biosimilars across the MENA region but also demonstrates our commitment to expanding access to innovative cancer therapies. Leveraging Formycon's scientific expertise with our established local capabilities and our advanced manufacturing facility in Saudi Arabia, we are well-positioned to deliver high-quality biosimilars that meet the needs of patients and healthcare systems in the MENA region," commented Kalle Känd, CEO of MS Pharma. Upon signature of the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, Formycon will further receive a significant share of the gross profits generated in the region. MS Pharma will continue to contribute to greater treatment availability while supporting national strategies focused on localization, resilience, and sustainable access to oncology care. This collaboration reinforces MS Pharma's role as a long-term partner to governments and healthcare institutions across the region, helping maintain continuity and quality of care for patients. Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 2024[2], Keytruda® is currently one of the world's best-selling drugs. In the MENA region, estimated sales reached approximately US$ 240 million[3], positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA. 1. Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA. 2. Announces Fourth-Quarter and Full-Year 2024 Financial Results – Merck.com. 3. IQVIA tender data, YTD June 2025. About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: . About MS Pharma: MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia – home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries. For more information, please visit: . About Biosimilars: Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030. Logo: Logo: Contact: Sabrina Müller Director Investor Relations & Corporate Communications Formycon AG Fraunhoferstr. 15 82152 Planegg-Martinsried Germany Tel.: +49 (0) 89 - 86 46 67 149 Fax: + 49 (0) 89 - 86 46 67 110 [email protected] Contact: Orayb Akeel Corporate Communications Director MS Pharma Amman – Jordan Tel: +962 (0) 77- 680 1114 [email protected] Disclaimer: This press release may contain forward-looking statements and information which are based on Formycon's current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States. SOURCE MS Pharma 21% more press release views with Request a Demo

License out/inDrug ApprovalBiosimilarImmunotherapy

14 Oct 2025

·www.prnewswire.com

Waltz Health and Serve You Rx Delivering Millions in Specialty Pharmacy Savings to Health Plans, Employers and Patients

Leveraging Waltz Connect, the collaboration reduced specialty prescription spend by 14% while also improving patient access and operational efficiency. MILWAUKEE and CHICAGO, Oct. 14, 2025 /PRNewswire/ -- Waltz Health, an EVERSANA company, today announced that its partnership with Serve You Rx is generating substantial savings through the use of Waltz Connect, Waltz Health's AI-powered specialty medication platform. From May through July 2025, the collaboration delivered an average savings per prescription of $917, representing a 14% overall cost reduction. The results translated into average savings of $238 per prescription for members and $679 for health plans and employers underscoring the shared impact. Serve You Rx integrated Waltz Connect, a specialty-drug savings platform that combines automated prescription routing technology with a dynamic marketplace that includes dozens of URAC-accredited specialty pharmacies, evaluating clinical requirements, pricing and eligibility to identify the most cost-effective and clinically appropriate pharmacy for each patient. This AI-driven, real-time optimization preserves clinical continuity while delivering substantial value. In addition to pharmacy optimization, which keeps the current therapy but sources at high quality, lower cost pharmacies, the model supports clinically appropriate brand-to-generic or biosimilar switches. In July, the program achieved a 90% biosimilar conversion rate, bolstered by Serve You Rx's Biosimilar Advantage Formulary, with significant per-prescription savings across high-cost categories: autoimmune therapies saw $1,177 in savings (~20%), and dermatology treatments had $505 in savings (~6%). Standout conversions included Humira to Amjevita ($6,072 saved per prescription), and Stelara to Wezlana ($23,500 saved per prescription), or Stelara to Otulfi ($25,081 saved per prescription). Process enhancements were also notable, with prior authorization turnaround times reduced by 50%– enabling faster access to medications with fewer delays. "Serve You Rx prides itself on disruptive flexibility and client-first solutions," said Justin Jasniewski, CEO of Serve You Rx. "By integrating Waltz Connect, we're bringing transparency, efficiency and affordability to specialty pharmacy, and these results demonstrate how powerful that innovation can be." Waltz Health and Serve You Rx plan to further scale the initiative, expanding biosimilar outreach, generic conversions and optimizing the pharmacy experience for patients and payers alike. "This partnership proves that cost savings and patient access can go hand in hand," said Jeff Park, President of Waltz Health. "Waltz Connect enables smarter pharmacy options and supports strategic biosimilar adoption, delivering real-world financial results without disrupting patient care." The results also underscore the strategic importance of Waltz Health's recent merger with EVERSANA that created a new force in pharma commercialization and prescription drug access. By combining Waltz's AI-driven pharmacy marketplaces with EVERSANA's deep commercialization expertise, the merged organization is uniquely positioned to bridge the gap between payers, PBMs and pharmaceutical manufacturers. Partnerships like Serve You Rx demonstrate how Waltz Health and EVERSANA can deliver immediate value to payers and their members, while also building the infrastructure to bring the life sciences ecosystem closer together – ultimately reducing costs, expanding access and ensuring patients receive the therapies they need. About Serve You Rx Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what's best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say "yes" to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service. To learn more, visit ServeYouRx.com. About Waltz Health Waltz Health, an EVERSANA company, is a digital health company developing technologies and services that support better-informed decisions on prescription care. Designed for payers, pharmacies, PBMs, and self-insured employers, the company offers AI-driven marketplaces to lower overall drug costs by providing better pricing options and more information for consumers, while enabling payers to take control of their pharmacy benefits. Founded in 2021 by Mark and Jonathon Thierer and headquartered in Chicago, Waltz Health is backed by GV, Define Ventures, Echo Health Ventures, Blue Venture Fund, Byers Capital and Twine Ventures. For more information, visit . Media Relations [email protected] SOURCE Waltz Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Acquisition

05 Aug 2025

·www.prnewswire.com

CivicaScript® to distribute low-cost biosimilar to treat chronic inflammatory conditions

January launch of ustekinumab-aauz to CivicaScript customers will expand company's rapidly growing product portfolio LEHI, Utah, Aug. 5, 2025 /PRNewswire/ -- CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines to U.S. patients, today announced that it will distribute the biosimilar ustekinumab-aauz, used for treatment of chronic inflammatory conditions in certain patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. The product will be available starting Jan. 1, 2026. Ustekinumab-aauz is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. Specific information about ustekinumab-aauz can be found here. The company's expansion into biosimilars builds on the steady growth of its specialty generic product portfolio, with four products launched in 2025. CivicaScript will be the exclusive distributor of unbranded ustekinumab-aauz, produced by Fresenius Kabi. Ustekinumab-aauz is interchangeable* to the reference product Stelara® (ustekinumab) injection for subcutaneous or intravenous use. CivicaScript will sell ustekinumab-aauz in prefilled syringes in two different strengths. The Wholesale Acquisition Price (WAC) for a 12-week supply of 90 mg will be $985 and the WAC for a 12-week supply of 45 mg will be $575. The biosimilar will be available at this low, transparent price to CivicaScript's members and partners, including health plans and pharmacy benefit managers. "The launch of ustekinumab-aauz is a major step forward in our mission to make essential medicines more affordable and accessible to all," said CivicaScript President Brent J. Eberle. "We're proud to offer a biosimilar that leverages our transparent business model to help reduce the financial burden on patients and the healthcare system. We expect this to be the first of several biosimilars we add to our portfolio over the next few years." About CivicaScript CivicaScript is bringing unprecedented transparency to the drug supply chain to make quality generic medicines affordable and available for everyone. A not-for-profit, limited liability company, CivicaScript is committed to the principles of providing affordable, essential generic medicines to promote the social welfare and health of the community. For more information on the organization and our mission, visit our website. CivicaScript is the Civica, Inc. operating unit for outpatient medications to help drive affordability and price transparency. About ustekinumab-aauz Indications Ustekinumab-aauz is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn's disease; moderately to severely active ulcerative colitis. Ustekinumab-aauz is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. Contraindications Ustekinumab-aauz is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in ustekinumab-aauz. *For more information, please see Prescribing Information. MEDIA CONTACT: Liz Power [email protected] +1 860 501 3849 SOURCE CivicaScript WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionDrug Approval

100 Deals associated with Ustekinumab-Aauz

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis	Canada	Fresenius Kabi Canada Ltd.	01 Dec 2024
Arthritis, Psoriatic	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	European Union	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Iceland	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Iceland	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Liechtenstein	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Liechtenstein	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Arthritis, Psoriatic	Norway	Formycon AG	25 Sep 2024
Arthritis, Psoriatic	Norway	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	European Union	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Iceland	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Iceland	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	Liechtenstein	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active moderate	Liechtenstein	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Norway	Formycon AG	25 Sep 2024
Crohn's disease, active moderate	Norway	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active severe	European Union	Fresenius Kabi Deutschland GmbH	25 Sep 2024
Crohn's disease, active severe	European Union	Formycon AG	25 Sep 2024
Crohn's disease, active severe	Iceland	Formycon AG	25 Sep 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immune System Diseases	Phase 1	-	Aristo Pharma GmbH	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	-	491	FYB202	jrikbucajp(svwxxyiemg) = All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration-time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%-125%. vssuutiojl (zkcknfufgj ) View more	Similar	19 Oct 2024
				EU-Ref
FDA_CDER Manual	Not Applicable	Crohn Disease	388	Placebo (CD-3)	lumszftzfh(stperlnzaw) = lrdaztowpf digtnglxbq (igqzgveomx ) View more	Positive	27 Sep 2024
				Ustekinumab (CD-3)	lumszftzfh(stperlnzaw) = fdqargzsob digtnglxbq (igqzgveomx ) View more
FDA_CDER Manual	Not Applicable	Crohn Disease	1,368	Placebo (CD-1)	fchrjrqipl(dfecoxlxfo) = crzlesyleb lczsaqedqq (kpjywzlwkd ) View more	Positive	27 Sep 2024
				Ustekinumab (CD-1)	fchrjrqipl(dfecoxlxfo) = ngakpojdde lczsaqedqq (kpjywzlwkd ) View more
FDA_CDER Manual	Not Applicable	Colitis, Ulcerative	961	Placebo (Prior biologic failure)	okmkitbfhr(rfnxgetulq) = fqusgfcaco wfqajozyfd (qneucvuwqq ) View more	Positive	27 Sep 2024
				Ustekinumab	okmkitbfhr(rfnxgetulq) = xshnrtruuf wfqajozyfd (qneucvuwqq ) View more
FDA_CDER Manual	Not Applicable	Plaque psoriasis	1,996	Placebo (Ps STUDY 1)	scmrwphaio(fyrvlwncrh) = bnxztfdfjn cnsloathow (bxpjpqmuuj ) View more	Positive	27 Sep 2024
				UstekinumabUstekinumab 45 mg (Ps STUDY 1)	scmrwphaio(fyrvlwncrh) = oqtufyeohr cnsloathow (bxpjpqmuuj ) View more
FDA_CDER Manual	Not Applicable	Arthritis, Psoriatic	927	Placebo (PsA STUDY 1)	trrahdeeps(gykpjlblks) = pybyjrjaes zijgwgtezk (cgoiovtgzz ) View more	Positive	27 Sep 2024
				Ustekinumab 45 mg (PsA STUDY 1)	trrahdeeps(gykpjlblks) = gdfkelfuea zijgwgtezk (cgoiovtgzz ) View more
FDA_CDER Manual	Not Applicable	Plaque psoriasis	73	Placebo	pbonuekrfw(qpysuatwdp) = pdrmmarmcz etmerddorb (ridkbjocyz ) View more	Positive	27 Sep 2024
				Ustekinumab	pbonuekrfw(qpysuatwdp) = qozktzxxmf etmerddorb (ridkbjocyz ) View more

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