Pembrolizumab

The US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for FYB206 for review. To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of a filing for a proposed biosimilar to Keytruda®. FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in early 2025. Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market for this product. Oct. 13, 2026 -- Zydus Lifesciences Limited (Zydus), an innovation-led global life-sciences company, and Formycon AG (Formycon), an independent developer of biosimilars, today jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the Biologics License Application ("BLA") for FYB206, a proposed biosimilar to Keytruda®1 (pembrolizumab). To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of an application for a Keytruda® biosimilar. The BLA was submitted in the third quarter of 2026. Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027. The regulatory dossier for FYB206 has also been submitted to Health Canada. Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited said, "Acceptance of the application marks a significant step toward expanding access to affordable pembrolizumab therapy in the U.S. and Canada. As demand for high-quality, accessible oncology treatments continues to rise, FYB206 has the potential to improve patient access and outcomes while strengthening our oncology biosimilars portfolio. Leveraging the biologics expertise of Formycon and our established oncology platform in North America, we remain focused on delivering meaningful value to patients." Dr. Stefan Glombitza, CEO of Formycon AG said, "With the FDA's acceptance of the FYB206 application for review, we are among the very first companies to advance a biosimilar to the world's best-selling biologic medicine to this stage. We developed FYB206 on a path agreed with the FDA, without conducting a comparative Phase III efficacy trial. This enabled us to accelerate the program and substantially reduce development investment while maintaining the rigorous scientific standards required for biosimilar approval. With Zydus, we have a partner with strong commercial capabilities and a clear oncology strategy in the US and Canada. Together, we aim to make this important cancer therapy accessible to more patients." Pembrolizumab is an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor and is used to treat numerous types of cancer. In 2025, worldwide sales of Keytruda®, including the subcutaneous formulation Keytruda Qlex™, reached USD 31.7 billion.2 In the first half of 2026, combined sales of Keytruda® and Keytruda Qlex™ totaled USD 16.40 billion.3 Keytruda® therefore remains the world's best-selling biologic medicine. In February 2025, Formycon agreed with the USFDA that FYB206 does not require a comparative Phase III efficacy trial. In December 2025, Formycon and Zydus had entered into an exclusive licensing and supply agreement for FYB206 in the United States and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product. With the USFDA's acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus. Zydus will commercialize FYB206 in both markets, subject to regulatory approval and resolution of any intellectual property issues. Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners. Keytruda® is a registered trademark and Keytruda Qlex™ is a trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ/USA. Merck & Co., Inc.: Annual Report on Form 10-K for the fiscal year 2025. Merck & Co., Inc.: Second-Quarter 2026 Financial Results, August 4, 2026: https://www.merck.com/news/merck-highlights-key-regulatory-and-clinical-milestones-across-broad-diverse-pipeline/ Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. The group employs 30,000 people worldwide, including 1,500 scientists engaged in research and development. Zydus is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that improve lives. Further information is available at www.zyduslife.com. Formycon AG is a listed, independent developer of biosimilars based in Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people. Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the U.S. alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible. The content above comes from the network. if any infringement, please contact us to modify.

Joint initiative demonstrates how risk-based, value-based partnerships can convert a well-established clinical practice into meaningful, scaled savings across a shared patient population NASHVILLE, Tenn., Oct. 15, 2026 /PRNewswire/ -- Thyme Care, the nationally recognized oncology company, and Texas Oncology, the nation's leading cancer care organization, today announced new data showing that weight-based dosing of pembrolizumab, delivered under a value-based care agreement, meaningfully reduced cost of care for their shared Medicare Advantage population. Findings will be presented as a poster at the American Society of Clinical Oncology (ASCO) Quality Care Symposium, October 16th through 17th, 2026, under the Cost, Value, and Policy track. Pembrolizumab, sold as Keytruda, accounts for a meaningful percentage of total cancer care spending in the United States. An incredibly effective drug, it is used to treat dozens of cancer types across both curative and non-curative treatment settings, extending life and improving quality of life. It is typically given at a fixed dose, though extensive evidence shows it can be dosed by patient weight instead, with no impact on efficacy. In fee-for-service oncology, the payment structure often disincentivizes decisions that can reduce drug spend in a clinically appropriate way. As a result, weight-based dosing has, to date, generally been adopted only within CMMI-sponsored value-based care arrangements like the Enhancing Oncology Model. This collaboration shows the same model working outside CMMI programs. Under Thyme Care's risk-based agreements with health plans, payment is tied to outcomes and total cost of care, so the plan and the practice are working toward the same patient-centric goal. That alignment lets Texas Oncology act on the evidence without taking on financial risk to do so, and makes weight-based dosing possible at scale across this population. "Texas Oncology has long been a leader in bringing innovative, evidence-based care to our patients. Thyme Care made the economics work for our practice, enabling our clinical pharmacy team to scale this work across our broader patient population," said Debra Patt, MD, PhD, MBA, FASCO, Executive Vice President, Policy and Strategic Initiatives, Texas Oncology. "This is what true value-based care looks like, and we're proud of what this partnership has accomplished.". Texas Oncology had already explored weight-based dosing within the Enhancing Oncology Model and the approach garnered success. Under Thyme Care's risk-based contracts, extending that approach across a broader, shared population required new workflows and bidirectional data sharing. Thyme Care created a technology-enabled pembrolizumab weight-based dosing program that identified eligible patients earlier using payer claims and prior authorization data, enabled two-way data exchange to identify stalled conversion opportunities, tracked results across multiple payer contracts, and routed every eligible patient through clinical pharmacist review, in partnership with the treating oncologist, before conversion. The analysis, conducted between September 2025 and April 2026, shows that across 613 pembrolizumab administrations, 55% were eligible for weight-based dosing based on patient weight, and 34% of those were successfully converted. By the final two months of that window, adherence consistently exceeded 45%. In total, the intervention reduced pembrolizumab utilization and lowered cost of care by more than $723,000, a 7.3% reduction against projected costs under standard dosing. "For decades we've talked about the cost of cancer drugs, and quite honestly few of the proposed solutions have been operationalized at a meaningful scale. Weight-based dosing is a good example. The evidence has been there, but it rarely happened outside of CMS models because the incentive model to do it didn't exist," Bobby Green, MD, co-founder, president, and chief medical officer at Thyme Care. "Our team at Thyme Care built it, and I'm grateful to them and to the Texas Oncology physicians and pharmacists who worked through it with us. We acted on the evidence and saw real savings. This is the kind of work we need to bring to the rising cost of treating cancer." The partnership continued to deliver results well beyond the original analysis window, reaching nearly 60% by June 2026. As the oncology treatment landscape continues to evolve, most recently with the introduction of a subcutaneous formulation of pembrolizumab, Thyme Care and Texas Oncology are using that same approach to identify the next set of high value interventions that could meaningfully reduce drug spend. About Thyme Care Thyme Care aligns accountability across the cancer care journey, coordinating patients, providers, and health plans around a shared model of care that drives better outcomes and lower costs for everyone. Through dedicated care teams and technology, Thyme Care integrates directly into existing workflows to support patients longitudinally, close gaps between visits, and align clinical decisions with financial accountability. To learn more, visit thymecare.com. About Texas Oncology With more than 550 physicians and 300 locations, Texas Oncology is an independent private practice that cares for more than 250,000 unique cancer patients each year. Founded in 1986, Texas Oncology provides comprehensive, multi-disciplinary care, and includes Texas Center for Proton Therapy, Texas Breast Specialists, Texas Colon & Rectal Specialists, Texas Oncology Surgical Specialists, Texas Urology Specialists, and Texas Infusion and Imaging Center. Texas Oncology's robust community-based research program has more than 3,000 active clinical trials and has contributed to the development of more than 100 FDA-approved cancer therapies. Learn more at TexasOncology.com. Contacts Thyme Care [email protected] Texas Oncology [email protected] SOURCE Thyme Care 21% more press release views with Request a Demo