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)…
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…
The world of biosimilar litigation is back in full swing with several BPCIA lawsuits currently pending. On October 12, 2023, in the second webinar in Goodwin’s 2023 Biosimilars Webinar Series, Goodwin IP Litigation partner and BMW Founding Editor, Elaine Blais, Goodwin IP Litigation partner and BMW Editor-in-Chief, Natasha Daughtrey and…
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…
Today, the Nobel Assembly at Karolinska Institutet announced that the Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman “for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA [messenger RNA] vaccines against COVID-19.” Dr. Karikó is a Professor at Szeged University and…
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation…
Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. market. Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation…
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl). Sarepta and Catalent each…
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…
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…