Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

To learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.

Start Date14 Jul 2023

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT05870748 / RecruitingPhase 2/3

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

Start Date12 Jul 2023

Sponsor / Collaborator

Sutro Biopharma, Inc.

[+2]

NCT05841186 / RecruitingPhase 2IIT

Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)

According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). However, pegfilgrastim-induced bone pain (PIBP) remains a common and significant clinical issue without a satisfactory solution. Studies have reported that the incidence rate of PIBP is 71.3%, with severe bone pain occurring in 27.0% of cases. Currently, the available data on PIBP treatment are limited to case reports, reviews, and small randomized controlled trials.
The NCCN guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for PIBP. However, even with these preventive measures, the incidence rate of PIBP remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. Severe bone pain can significantly impact the patient's health-related quality of life (HRQol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. Ultimately, this may have negative implications for tumor cure rates and patient survival.
Based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of PIBP. Therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of PIBP.

Start Date01 May 2023

Sponsor / Collaborator

Guangdong General Hospital

100 Clinical Results associated with Pegfilgrastim (Amgen)

100 Translational Medicine associated with Pegfilgrastim (Amgen)

100 Patents (Medical) associated with Pegfilgrastim (Amgen)

108

Literatures (Medical) associated with Pegfilgrastim (Amgen)

01 Jan 2024·European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

Aggregation of human plasma and of human blood induced in vitro by filgrastim originator product; effect of PEGylation

Article

Author: Dowd, Jason ; Ersayin, Nuri ; Cudd, Amelia ; Arvinte, Tudor ; Poirier, Emilie ; Darpin, Guillaume ; Brokx, Stephen

We herein report that filgrastim product Neupogen® and the filgrastim formulation buffer induced aggregate formation when mixed in vitro with human plasma, and formation of large membranous erythrocyte aggregates when mixed with human blood, similar to the aggregation induced by pegfilgrastim and by pegfilgrastim buffer [T. Arvinte, E. Poirier, N. Ersayin, G. Darpin, A. Cudd, J. Dowd, S. Brokx, Aggregation of human plasma and of human blood induced in vitro by pegfilgrastim originator formulation buffer and pegfilgrastim products, Eur. J. Pharmaceut. Biopharmaceut. (2023), doi: 10.1016/j.ejpb.2023.10.019]. The data identify the filgrastim buffer (which is practically the same in filgrastim and pegfilgrastim products) as the main driver of human plasma and blood aggregation. Kinetic experiments showed differences in the extent of plasma aggregation induced by a filgrastim product manufactured in EU and one manufactured in USA. Human donor variability in the plasma aggregation induced by filgrastim was observed. To study the effect of PEGylation of the filgrastim protein on plasma aggregation we compared filgrastim (Neupogen®) with pegfilgrastim (Neulasta®) solutions at the same protein concentration. These data show that PEGylation has a beneficial effect in inhibiting to an extent plasma aggregation. Interestingly, 20 kDa polyethylene glycol in the filgrastim buffer induced more plasma aggregation compared to the buffer, similar to the aggregation induced by pegfilgrastim. For intravenous infusion filgrastim solutions (300 µg/ml, vials only) may be diluted in 5 % dextrose from a concentration of 300 µg/ml to 5 µg/ml. Aggregation of human plasma was also induced by filgrastim solutions diluted in 5 % dextrose to 50 µg/ml, 15 µg/ml and 5 µg/ml filgrastim, as well as by the filgrastim buffer similarly diluted in 5 % dextrose (1:6, 1:20 and 1:60 dilution). These data show that filgrastim solutions used for intravenous administration in patients induce human plasma aggregation in vitro. Such aggregation phenomena may be related to known infusion side effects of filgrastim therapy.

31 Dec 2023·Journal of medical economics

Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study

Article

Author: Yousef, Consuela Cheriece ; Al-Foheidi, Meteb ; AlAbdalkarim, Hana ; Alshamrani, Majed ; AlJedai, Ahmed ; Naeem, Anjum ; Khan, Mansoor Ahmed ; Almodaimegh, Hind ; Abraham, Ivo

AIMS:

This study estimated, for Saudi Arabia, the cost-efficiency of converting patients from reference Neupogen and Neulastim to one of two filgrastim biosimilars (Nivestim, Zarzio); the budget-neutral expanded access to supportive care with biosimilar filgrastim and therapeutic care to ado-trastuzumab emtansine thus afforded; and the number-needed-to-convert (NNC) to provide supportive or therapeutic treatment to one patient.

MATERIALS AND METHODS:

Replicating prior studies, we modeled the cost-efficiencies gained from converting varying proportions of a hypothetical panel of 4,000 patients undergoing six cycles of cancer treatment from Neupogen or Neulastim to one of the two biosimilar G-CSF formulations, using national cost inputs. Cost-savings in USD were used to estimate the additional doses of biosimilar G-CSF and expanded access to ado-trastuzumab emtansine on a budget-neutral basis, and NNC to purchase one additional dose of supportive or therapeutic treatment.

RESULTS:

Savings from conversion from reference to a biosimilar filgrastim were $3,086,400 (Nivestim) and $3,460,800 (Zarzio). With reference pegfilgrastim, savings from conversion were $11,712,240 (Nivestim) and $12,086,640 (Zarzio). Biosimilar conversion from reference to biosimilar filgrastim enabled expanded access to ado-trastuzumab emtansine ranging from 61 patients (5 days, Nivestim) to 191 patients (14 days, Zarzio). For supportive care, biosimilar conversion enabled expanded access ranging from 8,244 patients (5 days, Nivestim) to 25,882 patients (14 days, Zarzio). For biosimilar conversion from daily filgrastim, the NNC for treatment with ado-trastuzumab emtansine decreased as days of injections increased [5 days: 395 (Nivestim), 352 (Zarzio); 14 days: 141(Nivestim), 126 (Zarzio)]. Alternately, for biosimilar conversion from single-injection pegfilgrastim to daily biosimilar filgrastim, the NNC for treatment with ado-trastuzumab emtansine rose as days of injections increased, being highest under the 14-day scenario (146, Nivestim; 130, Zarzio).

CONCLUSION:

This simulation study demonstrated significant potential cost-savings from biosimilar conversion. These savings provide budget-neutral increased access to supportive and therapeutic cancer care.

01 Nov 2023·JCO oncology practice

Sustainable Integration of US Food and Drug Administration–Approved Biosimilars: Pharmacy- Versus Physician-Driven Change

Article

Author: Mendenhall, Molly A ; Davies, Daniel ; Waterhouse, David M ; Ward, Patrick ; Drosick, David R ; Burdette, Caleb

PURPOSE:

Biosimilars are clinically equivalent to branded products yet cost significantly less. Interchangeability is a US Food and Drug Administration (FDA) designation that allows generic drugs to be substituted for reference drugs at the pharmacy, without a physician's consent. Currently, no oncologic biosimilar has FDA approval for interchangeability.

METHODS:

Building on pharmacy auto-substitution processes with therapeutic interchange, Plan-Do-Study-Act methodology was used to automate conversions from reference biological products to Pharmacy and Therapeutics–/Physician-approved biosimilars. After establishing the baseline metrics, cycle 1 focused on full staff education (completed July 2020) with systematic pharmacy-driven biosimilar conversion initiated in September 2020 for rituximab, trastuzumab, and bevacizumab. Physician-initiated conversion of Neulasta biosimilar products was encouraged but not mandated. During cycle 2 (May 1, 2021-November 30, 2021), pharmacy-driven Neulasta biosimilar conversion was mandated. In cycle 3 (December 1, 2021-April 30, 2023), stakeholder education was reinforced and the sustainability of conversions was confirmed.

RESULTS:

Systematic pharmacy-driven conversion to biosimilar products improved over cycles 1 and 2 from baseline: 1.8% to 90.3% for rituximab, 9.2% to 89.7% for trastuzumab, and 20.5% to 96.1% for bevacizumab. Physician-driven biosimilar conversion for Neulasta was lower at 12.7% through April 2021. Pharmacy-driven Neulasta biosimilar conversion was initiated during cycle 2, resulting in a conversion rate of 39.7%. The conversion rates remained sustainable through April 2023.

CONCLUSION:

Pharmacy-driven auto-substitution of biosimilar products results in rapid and statistically significant biosimilar adoption. The pharmacy-based substitution approach was found to be far more effective than physician-driven substitution. Rapid conversion from branded products to FDA-approved biosimilar is feasible, measurable, and sustainable and can be scaled. Barriers to Neulasta conversion warrant further investigation.

145

News (Medical) associated with Pegfilgrastim (Amgen)

27 Jun 2024

·pipelinereview.com

Meitheal Pharmaceuticals Strengthens Biologics Portfolio with an Exclusive Commercial Licensing Agreement for YUSIMRY®, a Biosimilar of Humira®

CHICAGO, IL, USA I June 27, 2024 I Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has gained exclusive commercial rights in the U.S. to YUSIMRY ® (adalimumab-aqvh), a biosimilar of Humira ® (adalimumab), through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”). “The licensing of YUSIMRY ® is a pivotal moment for Meitheal, solidifying our foothold in the biosimilars market and providing us with a high-value asset with the potential for robust growth in the coming years,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “With our expertise across research, manufacturing, and commercialization, Meitheal is well-positioned to enhance patient access to high-quality biosimilars like YUSIMRY ® while continuing to advance its clinical and commercial development.” HKF has acquired worldwide rights to YUSIMRY ® through an asset purchase agreement with Coherus BioSciences, Inc. Under the agreement, HKF gains substantially all assets related to YUSIMRY ® , including any results of development and regulatory activities, in exchange for an upfront cash payment of $40,000,000. The closings of both the asset purchase agreement and Meitheal’s exclusive licensing agreement with HKF are effective immediately, subject to standard conditions and approvals. “Adalimumab is a critical medication for many Americans living with autoimmune conditions, and we look forward to continuing to deliver YUSIMRY ® , a more affordable option to Humira ® , to patients at a fair and sustainable price,” said Brian McCarthy, Meitheal Senior Vice President of Specialty. “With adalimumab biosimilars recently gaining traction, YUSIMRY ® is positioned to meet the ongoing demand for accessible treatment options due to key macro forces and the strategic investments being made in its production and commercialization.” In recent years, Meitheal and its parent company HKF have made multiple investments to expand the Company’s biologics portfolio and capabilities. This new, exclusive licensing agreement for YUSIMRY ® adds a fifth biosimilar and the first on-market biosimilar to Meitheal’s portfolio. Meitheal’s parent company and related entities have invested over $300 million in capital and R&D in recent years to support sustainable product supply, including investing $30 million in a monoclonal antibody drug substance facility. “We are pleased to have acquired the rights to this critical option for patients and are confident that Meitheal is best positioned to deliver fairly priced YUSIMRY ® to U.S. patients in need,” said Eric Tang, President of HKF. “We remain focused on strategic investments in the important biosimilars market and we look forward to a continued partnership with Meitheal to support accessible healthcare solutions.” YUSIMRY ® is currently approved by the U.S. Food and Drug Administration (“FDA”) in nine different indications as a biosimilar of Humira ® , including in both prefilled syringe (PFS) and autoinjector presentations. As a top-selling pharmaceutical for multiple inflammatory diseases, demand for adalimumab products remains high. Meitheal will continue the development of both pediatric presentations and a high concentration (100mg/mL) formulation of YUSIMRY ® . Meitheal will work closely with Coherus to ensure a seamless transition of existing YUSIMRY ® operations, including the existing and comprehensive support hub for patients and healthcare providers. ABOUT YUSIMRY ® YUSIMRY ® (adalimumab-aqvh), a biosimilar of Humira ® (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing sponddylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. INDICATIONS Limitations of Use: The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of YUSIMRY has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Please see Full Prescribing Information , including Boxed Warning and Medication guide ABOUT MEITHEAL PHARMACEUTICALS Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 55 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of May 2024, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 14 products planned for launch in 2024, and an additional 19 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked among the top 100 Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of NKF, founded in 2010. ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. ABOUT COHERUS BIOSCIENCES Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the novel pathway ILT4. Coherus markets LOQTORZI ® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor and UDENYCA ® (pegfilgrastim-cbqv), a biosimilar of Neulasta ® (pegfilgrastim). SOURCE: Meitheal Pharmaceuticals

License out/inDrug ApprovalImmunotherapyPhase 1Phase 2

23 May 2024

·www.biospace.com

Coherus Presents Preliminary Results from Phase I Dose Escalation Study of its Anti-chemokine receptor 8 (CCR8) Antibody, CHS-114, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

CHS-114 shown to have an acceptable safety pro no dose-limiting toxicities (DLTs) in heavily pretreated patients with solid tumors Selective depletion of peripheral CCR8+ regulatory T cells (Tregs) was observed and depletion was maintained over the dosing interval, establishing proof of mechanism Preclinical data and preliminary clinical results support further evaluation of CHS-114 in combination with the anti-programmed cell death protein 1 (PD-1) antibody, toripalimab-tpzi, and other immuno-oncology (IO) agents REDWOOD CITY, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced clinical data from the CHS-114, single agent dose escalation stage of its Phase 1 study at the ASCO Annual Meeting, taking place May 31 to June 4, 2024, at McCormick Place in Chicago. CHS-114 is a novel afucosylated human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that selectively and potently targets human CCR8 with no off-target binding. CCR8 is a G protein-coupled receptor (GPCR) that shows preferential expression on tumor resident Treg cells and has promise as a drug target for selectively targeting immune suppression in the tumor microenvironment (TME) without broadly depleting Treg cells, which has the known unwanted side effect of autoimmune activation. “The Phase 1 preliminary dose escalation results are an important milestone as we progress our innovative I-O pipeline. We are very pleased with the safety profile, the predictable dose proportional pharmacokinetic profile, and the selective depletion of peripheral CCR8+ Tregs that were observed,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “By targeting CCR8, we believe CHS-114 has the potential to overcome Treg immune suppression in the TME and allows T cell recruitment, which turns cold tumors hot and enhances anti-tumor activity when combined with I-O agents. The data support further evaluation of CHS-114 in combination treatment with our anti-PD-1 antibody, toripalimab, and other I-O agents.” CCR8 is a chemokine receptor predominantly expressed by tumor infiltrating Tregs that suppress the body’s natural anti-cancer immune response. Targeting CCR8 is a promising potential therapeutic strategy designed to selectively deplete intratumoral CCR8+ Tregs, reshape the tumor microenvironment by alleviating local immunosuppression, and enhance anti-tumor immune response when combined with I-O agents. Data presented at ASCO demonstrate proof of mechanism for selective depletion of CCR8+ Tregs and an acceptable safety pro date. Poster presentation: Abstract # 2664: Preliminary Results of a Phase 1, First-in-human, Dose Escalation Study of the Anti-CCR8 Cytolytic Antibody, CHS-114 (formerly SRF114) in Patients with Advanced Solid Tumors. Poster Session: Developmental Therapeutics - Immunotherapy Date and Time: Saturday, June 1, 2024, 9:00 a.m. – 12:00 p.m. Central Daylight Time Poster presentation data are summarized as follows: CHS-114 has demonstrated an acceptable safety pro 20 evaluable, heavily pre-treated patients with advanced solid tumors, with no DLTs reported to date. Treatment emergent adverse events (TEAEs) were generally low grade. One patient experienced a treatment-related serious adverse event (SAE) of Grade 2 colitis. There were no treatment related adverse events (AEs) leading to discontinuation or death. CHS-114 PK exposure was approximately dose proportional, and the elimination appeared linear with a half-life of about 10 days (range 9-17 days). Depletion of peripheral CCR8+ Treg cells was observed and depletion was maintained over the dosing interval, establishing proof of mechanism. Preliminary results and acceptable safety pro further evaluation of CHS-114 in combination treatment with toripalimab and other I-O agents. In 19 patients evaluable for response, no objective responses were yet noted, while the stable disease rate was 47%. About the Phase 1 trial (NCT05635643): SRF114-101 is a Phase 1, First-In-Human, open-label, dose escalation study, evaluating CHS-114 as a single agent and in combination with toripalimab. The study enrolled patients with advanced solid tumors who received more than one line of prior treatment (75% had more than three prior lines). Stage 1a of the study included CHS-114 administered intravenously (IV) on day one of each Q3W cycle as part of single-agent dose escalation and employed the Bayesian optimal interval (BOIN) design, including accelerated titration and 3+3 run-in. Stage 1b will enroll an additional five patients with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) at each of two dose levels. Primary endpoints: rate of DLTs and TEAEs, with the overarching objective of determining two recommended doses for expansion (RDE). Key secondary endpoints: objective response rate (ORR) based on Investigator review per RECIST v1.1, pharmacokinetics, pharmacodynamic assessments (changes in FOXP3 expression within tumor tissue –Stage 1b). Exploratory pharmacodynamic endpoint: Changes in frequency of CCR8-expressing immune cell subsets in the periphery. About CHS-114 CHS-114, a human, afucosylated anti-CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially deplete CCR8+ Tregs within the tumor microenvironment, while preserving effector T (Teff) cells in tumors or Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in a Phase 1 clinical trial (NCT05635643) as a monotherapy and in combination with toripalimab in advanced solid tumors, including head and neck cancer. As reported in June 2023, early evidence of biological effect has been seen with CCR8+ Tregs depletion in blood following treatment with CHS-114, with no effect observed on non-CCR8+ Tregs. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on researching, developing, and commercializing innovative therapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline expected to synergize with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the novel pathway ILT4, with a response from the FDA on Coherus’ IND filing expected in the second quarter of 2024. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and YUSIMRY® (adalimumab-aqvh), a biosimilar of Humira®. Neulasta® is a registered trademark of Amgen, Inc. Humira® is a registered trademark of AbbVie Inc. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to identify synergies between its I-O pipeline and its commercial capabilities; Coherus’ expectation for the timing of the FDA’s response for its IND for CHS-1000; Coherus’ expectation that CHS-114 has the potential to overcome Treg immune suppression in the TME; and Coherus’ expectations that its immunotherapy candidates will enhance outcomes for patients with cancer. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance, or achievements to differ significantly from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the preclinical and clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risks of competition; the risk that Coherus is unable to complete commercial transactions; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024 filed with the Securities and Exchange Commission on May 9, 2024, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission. UDENYCA®, YUSIMRY® and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information: For Investors: Jami Taylor Head of Investor Relations IR@coherus.com For Media: Jodi Sievers VP, Corporate Communications media@coherus.com

Phase 1ImmunotherapyASCOClinical ResultPhase 2

09 May 2024

·www.biospace.com

Coherus Announces Full Repayment of Pharmakon Advisors $75 Million Term Loan

– New $38.7 million term loan with a May 2029 maturity– – $37.5 million royalty monetization financing based on future sales of LOQTORZI® and UDENYCA®– REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced it entered into a combined term loan and product royalty financing agreement with Barings that has allowed Coherus to fully pay off the remaining $75 million of its Pharmakon Advisors term loan. This further reduces the Company’s term loan debt by approximately half, with an extended loan maturity date of May 2029. “This debt and royalty financing arrangement fully repays the $75 million remaining on our prior $250 million term loan that was due in October 2025,” said Denny Lanfear, Chief Executive Officer of Coherus. “This transaction improves our capital structure, moves the maturity date to a point more consistent with our development horizon, setting us on the course of long-term, sustainable growth as a focused oncology company.” Under the terms of the royalty monetization facility, Coherus received $37.5 million in return for a certain net sales royalty percentage consideration on U.S. sales of LOQTORZI® and UDENYCA® up to a hard cap. Under the term loan, Coherus received $38.7 million in proceeds from a structured debt loan with a May 2029 maturity. Barings LLC is a global asset management firm supporting leading businesses with flexible financing solutions. Latham & Watkins LLP provided legal counsel and Armentum Partners, LLC advised Coherus on the financing. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline expected to synergize with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1 study as a monotherapy in patients with advanced solid tumors. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the pathway ILT4. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and YUSIMRY® (adalimumab-aqvh), a biosimilar of Humira®. Neulasta® is a registered trademark of Amgen, Inc. Humira® is a registered trademark of AbbVie Inc. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the impact of the transaction with Barings, LLC including improving Coherus’ capital structure and setting it on the course of long-term, sustainable growth as a focused oncology company. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risks of competition; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ products and product candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission on March 15, 2024, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission. Coherus’ results for the fiscal year ended December 31, 2023 are not necessarily indicative of its operating results for any future periods. UDENYCA®, UDENYCA® ONBODY™, YUSIMRY® and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information: For Investors: Jami Taylor Head of Investor Relations IR@coherus.com For Media: Jodi Sievers VP, Corporate Communications media@coherus.com

Phase 1ImmunotherapyPhase 2Financial Statement

100 Deals associated with Pegfilgrastim (Amgen)

External Link

KEGG	Wiki	ATC	Drug Bank
D06889	Pegfilgrastim (Amgen)	L03AA13	DB00019

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Stem cell mobilisation	JP	Kyowa Kirin Co., Ltd.	25 Feb 2022
Neutropenia	EU	Amgen Europe BV	22 Aug 2002
Neutropenia	IS	Amgen Europe BV	22 Aug 2002
Neutropenia	LI	Amgen Europe BV	22 Aug 2002
Neutropenia	NO	Amgen Europe BV	22 Aug 2002
Febrile Neutropenia	US	Amgen, Inc.	31 Jan 2002
Infectious Diseases	US	Amgen, Inc.	31 Jan 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 2	JP	Kyowa Kirin Co., Ltd.	01 Sep 2021
Breast Cancer	Phase 2	US	Amgen, Inc.	17 Jan 2013
Ostealgia	Phase 2	US	Amgen, Inc.	17 Jan 2013
Neoplasms	Phase 2	FR	Amgen, Inc.	12 Sep 2008
Bone Marrow Neoplasms	Phase 2	FR	Amgen, Inc.	01 Sep 2008
Lymphoma	Phase 2	FR	Amgen, Inc.	01 Sep 2008
Recurrent ovarian cancer	Phase 2	-	Amgen, Inc.	01 Oct 2003
Hodgkin's Lymphoma	Phase 2	-	Amgen, Inc.	01 Apr 2003
Non-Hodgkin Lymphoma	Phase 2	-	Amgen, Inc.	01 Apr 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GU2024 Manual	Not Applicable	Germ Cell and Embryonal Neoplasms	196	bleomycin+Pegfilgrastim	ahibqefswv(nieavnfser) = lrylbeunir gzcdwszgvv (rxqbeimkdy ) View more	Positive	25 Jan 2024
				bleomycin	ahibqefswv(nieavnfser) = jjwjuzbvjo gzcdwszgvv (rxqbeimkdy ) View more
JPRN-UMIN000028055 (ASCO_GI2024) Manual	Phase 2	Pancreatic adenocarcinoma	34	5-fluorouracil+leucovorin+irinotecan+ oxaliplatin (without pegfilgrastim)	kujfidgazc(xnususvney) = jkgvyqsyxs jfbiuloerl (qgwedsvkpe ) View more	Positive	18 Jan 2024
EHA2022	Not Applicable	Multiple Myeloma	57	Pegfilgrastim	qnvwbfomhf(yfuvdppdww) = rcvqlzrqmb tmavwhnces (emkpbgtqob ) View more	-	10 Jun 2022
NCT02698891 (CTgov)	Phase 2	Early Stage Breast Carcinoma	127	Neulasta+Paclitaxel	uktbqppaqr(txstqjtktv) = uvodmksvow zcegnowvze (azypfidzcb, xhdklxjvpc - qgjyabnyxv) View more	-	06 May 2022
JPRN-UMIN000017538 (Pubmed \| Int J Clin Oncol)	Phase 2	Secondary malignant neoplasm of pancreas	22	FOLFIRINOX with primary prophylactic pegfilgrastim	hqjyubprxa(abwtfwbcpg) = uzryivwvfe hboapjesly (mwbcrbzljr, 0.5 - 40.3) View more	-	01 Nov 2021
PROTECTIVE-2(BPI-2358-106) (CSCO2021)	Phase 3	Poikiloderma With Neutropenia	221	普那布林 40mg+培非格司亭 6mg	vmwsbnafiy(nbdckmlmfc) = bkgxeeryzp alfdusbmxy (yvvbagnjiy ) View more	-	25 Sep 2021
				培非格司亭 6mg+安慰剂	vmwsbnafiy(nbdckmlmfc) = smyggcvbzl alfdusbmxy (yvvbagnjiy ) View more
PROTECTIVE-2 (CSCO2021)	Phase 3	Neutropenia	221	普那布林40mg+培非格司亭6mg	sksblnzzff(dymxjznbql) = sgzebkvyws nmirfepiqv (gkhcnnwhxj ) View more	Positive	25 Sep 2021
				培非格司亭6mg+安慰剂	sksblnzzff(dymxjznbql) = hthadjoews nmirfepiqv (gkhcnnwhxj ) View more
NCT02578732 (BrUOG 318, CTgov)	Phase 2	Locally Advanced Pancreatic Adenocarcinoma	28	FOLFOXA	widqwuzulo(bducnyetfn) = rgiztivdew jufuvuhuyq (wwhxrlpejr, okfgjuetyl - qkwjwlexfx) View more	-	13 Aug 2021
NCT03511378 (CTgov)	Phase 4	Breast Cancer	138	Lupin's Pegfilgrastim (Lupin's Pegfilgrastim)	dlqbbbfqhc(cgcspermjj) = horplfzobs qpbrhrckkb (qeelgmjtty, uefgxtsxci - dbsaueramt) View more	-	15 Jun 2021
				Neulasta® (Neulasta®)	dlqbbbfqhc(cgcspermjj) = rykukacphd qpbrhrckkb (qeelgmjtty, nluzepupnm - kemtwdrsjj) View more
P126 (EBMT2021)	Not Applicable	Multiple Myeloma	110	Pegylated G-CSF	ckecohwlvk(uoulfqgsir) = irgjmfozev tqjxavlqty (bxsizhofqm ) View more	Positive	14 Mar 2021
				G-CSF	ckecohwlvk(uoulfqgsir) = mnuvaoacis tqjxavlqty (bxsizhofqm ) View more

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