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.

Update on Recent International Biosimilar Approvals

Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA.  TYENNE is the first tocilizumab biosimilar approved in the EU.  TYENNE received approval for both subcutaneous (prefilled syringe…

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.”  FDA noted that this 2023 Draft Guidance reflects recommendations based on the “valuable experience about labeling considerations” that FDA…

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Update on mRNA Vaccine Patent Litigation

We previously reported on patent infringement litigations between Alnylam and Moderna.  Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna. First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively, “Moderna”), the parties entered a…

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Generic and Biosimilar Drugs Save $408B For America’s Patients and Healthcare System in 2022

On September 6, 2023, the Association for Accessible Medicines (AAM) released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar medicines.  Notably, the U.S. healthcare system, including patients, employers and taxpayers, saved $408 billion in 2022 by using FDA-approved generic and…

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Legal Challenges to the Inflation Reduction Act: An Update on Pending Challenges and Reactions to Oral Argument in Dayton Area Chamber Of Commerce et al. v. Becerra et al.

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other interested groups have filed lawsuits challenging the Program. In one of…

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Sandoz Receives FDA Approval for TYRUKO® (natalizumab-sztn), the First and Only FDA-Approved Biosimilar for Relapsing Forms of Multiple Sclerosis

On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar TYRUKO® (natalizumab-sztn), developed by Polpharma Biologics. TYRUKO® injection is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). TYRUKO® is also indicated for inducing and maintaining clinical response and remission in adult patients…

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Formycon Announces FDA Acceptance of the aBLA for Its Aflibercept Biosimilar

On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept).  As we previously reported, when Formycon submitted its aBLA in June 2023, it became the second biosimilar developer to announce…

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PTAB Issues Final Written Decisions Finding Claims of Tocilizumab-related Patents Invalid

On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc.  The ’264 patent claims are directed to…

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Celltrion Stelara (Ustekinumab) Settlement With J&J

It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA. This settlement…

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