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.

Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab).  The settlements cover Canada, the European Economic Area, and Japan, clearing the way for Alvotech to launch AVT04 in those markets, where AVT04 has already received regulatory approval. …

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FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated…

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PTAB Institutes Celltrion and Biocon IPRs on Regeneron Aflibercept Dosing Patent

Late last month, a Patent Trial and Appeal Board (“PTAB”) panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review (“IPR”) of Regeneron’s U.S. Patent 11,253,572 (“the ’572 patent”) and joined the two IPR proceedings with a pending IPR proceeding filed by Samsung Bioepis…

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FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” …

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Court Dismisses PhRMA Lawsuit Challenging IRA

Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation Reduction Act.  The lawsuit was brought by three Plaintiffs: PhRMA, the Global Colon Cancer Association, and the…

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Updates on Aflibercept BPCIA Litigation

Regeneron files ex parte application for a preliminary injunction schedule in case against Amgen On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency status conference.  Regeneron requested that…

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Sandoz to Acquire CIMERLI from Coherus for $170 Million

On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. (“Coherus”) for an upfront cash purchase payment of USD 170 million. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access…

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Biosimilar Regulatory Updates

Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar.  CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor antagonist indicated for adult rheumatoid arthritis, juvenile idiopathic polyarthritis, and systemic juvenile…

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USPTO Publishes Enablement Guidelines in view of Amgen v. Sanofi

On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major changes to USPTO practice or procedure” but instead “incorporat[e] guidance from the Amgen decision…

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