Welcome to the Big Molecule Watch!

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Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

Genentech and Biogen File Joint Stipulation of Dismissal in BPCIA Litigation Regarding Tocilizumab

As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…

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Amneal Expands Oncology Offering with Two Denosumab Biosimilars

On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries. Amneal announced that mAbxience will develop…

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Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).” Individualized CGTs are therapies “developed for a single patient (or a very small…

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Celltrion Expands Access to YUFLYMA (adalimumab-aaty)

On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.”  According to the press release, YUFLYMA (adalimumab-aaty) will be a…

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Meitheal Announces Exclusive Commercial Licensing Agreement for Insulin Biosimilars in the US

Meitheal Pharmaceuticals, Inc. (“Meitheal”) has entered into an exclusive licensing deal with Tonghua Dongbao Pharmaceutical Co., Ltd. (“THDB”) to market three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the United States.  The agreement grants Meitheal and its parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”), exclusive…

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Update on Ophthalmic Anti-VEGF Therapeutics

Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. EYLEA® HD (Aflibercept, 8 mg) Regeneron announced positive two-year (96 weeks) results from its PULSAR trial investigating Eylea® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA® (aflibercept, 2 mg)…

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Recent Adalimumab Biosimilar Developments

FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was…

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Biogen Announces FDA Approval of TOFIDENCE, a Tocilizumab Biosimilar Referencing ACTEMRA

On September 29, 2023, Biogen announced the FDA approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation which is the first tocilizumab biosimilar approved by the FDA in the United States.  TOFIDENCE is approved for the treatment of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile…

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