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Pharmaceutical Industry › Mylan Pharmaceuticals › FDA Approval

Goodwin

Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation

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On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re:...more

Goodwin

Recent Biosimilar Approvals By the FDA

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Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN...more

Goodwin

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2020

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As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more

Robins Kaplan LLP

Hatch-Waxman Venue Is Further Narrowed

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This week, the Federal Circuit issued an order finding that in cases brought under 35 U.S.C. § 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an Abbreviated...more

Goodwin

FDA Approves Mylan’s Biosimilar of HUMIRA (Adalimumab)

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On July 6, 2020, the U.S. FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA. HULIO is indicated for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis,...more

Goodwin

FDA Approves NDA for Semglee (insulin glargine injection)

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Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.  Semglee’s amino acid...more

Goodwin

EYLEA (Aflibercept) Biosimilar Development Updates

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Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more

Goodwin

Biocon: “Mylan Has Launched” Fulphila™ (pegfilgrastim-jmdb) Biosimilar in the U.S.

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As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the United States. Mylan stated at the time that...more

Goodwin

BREAKING NEWS: U.S. FDA Approves First Pegfilgrastim Biosimilar (UPDATED)

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Today, the U.S. FDA announced that it has approved Mylan’s aBLA for Fulphila™ (pegfilgrastim-jmdb), a biosimilar of Amgen’s Neulasta®. This approval marks the eleventh FDA licensure of a biosimilar product under the BPCIA...more

Jones Day

Tribal Sovereign Immunity Doctrine Does Not Insulate Tribes From Board Actions

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In a case of first impression, the PTAB recently decided that the doctrine of tribal sovereign immunity does not apply to inter partes review proceedings. See Mylan Pharmaceuticals Inc. v. Saint Regis Mohawk Tribe,...more

Goodwin

Year in Review: The Top-Five U.S. Market Developments of 2017

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Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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