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Biosimilars FDA Approval

Goodwin

Alvotech and Teva Announce FDA Approval of Additional Presentation for Ustekinumab Biosimilar

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On October 22, 2024, Alvotech and Teva announced that SELARSDI™ (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion....more

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Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA

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On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more

Venable LLP

Fresenius Kabi and Formycon Announce Approval of Stelara® Biosimilar Otulfi™ in the U.S. and E.U.

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On September 27, 2024, the FDA approved a fourth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab): Fresenius Kabi and Formycon’s Otulfi™ (ustekinumab-aauz). Fresenius and Formycon announced Oltufi™’s...more

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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

Venable LLP

Spotlight On: Biosimilar Litigations - September 2024

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

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FTC Comment on FDA Draft Guidance on Interchangeability

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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Venable LLP

Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval

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Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv).  The Complaint alleges infringement of 46 of...more

Venable LLP

Fifth EYLEA® Biosimilar FDA-Approved: Amgen’s Pavblu™ (aflibercept-ayyh)

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On August 23, 2024, the FDA approved Amgen’s Pavblu™ (aflibercept-ayyh) as the fifth biosimilar of Regeneron’s EYLEA® (aflibercept). Pavblu™ was approved with a skinny label that includes neovascular (wet) age-related macular...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Please see full Newsletter below for more information....more

Venable LLP

EYLEA® Biosimilar Updates: Sandoz’s Enzeevu™ (aflibercept-abzv) FDA Approved, Regeneron Dismisses IPR Appeals

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On August 12, 2024, Sandoz announced the FDA approval of Enzeevu™ (aflibercept-abzv) as the fourth biosimilar of Regeneron’s EYLEA® (aflibercept).  Enzeevu™ was approved as provisionally interchangeable, subject to the...more

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FDA Approves Sandoz’s ENVEEZU™ (aflibercept-abzv)

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​​​​​​​On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet)...more

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FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

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​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

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STADA and Alvotech Announce Launch of UZPROVO® in Europe

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​​​​​​​On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more

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FDA Approves Samsung’s Eculizumab Biosimilar

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​​​​​​​Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal...more

Venable LLP

FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar - Samsung Bioepis’s Epysqli® (eculizumab-aagh)

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On July 19, 2024, the FDA approved the second biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), Samsung Bioepis’s Epysqli® (eculizumab-aagh), approximately one year after Samsung Bioepis announced the FDA...more

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Venable’s BiologicsHQ Monthly Injection - June 2024

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Venable’s BiologicsHQ Monthly Injection – June 2024...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

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Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

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FDA Approves Ustekinumab, Aflibercept, and Filgrastim Biosimilars

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On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab)....more

Venable LLP

FDA Approves Three Biosimilars - Ahzantive® (aflibercept-mrbb), Nypozi™ (filgrastim-txid), and Pyzchiva® (ustekinumab-ttwe)

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On June 28, 2024, the FDA approved three new biosimilars, Formycon and Klinge Biopharma’s Ahzantive® (aflibercept-mrbb), a biosimilar of Regeneron’s EYLEA® (aflibercept); Tanvex Biopharma’s Nypozi™ (filgrastim-txid), a...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - May 2024

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Venable’s BiologicsHQ Monthly Injection - May 2024...more

Goodwin

Updates on Aflibercept Biosimilar Approvals and BPCIA Litigation

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Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI...more

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FDA Approves Amgen’s BKEMV, the First Eculizumab Biosimilar

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​​​​​​​On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab).  BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous...more

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Denosumab Biosimilar Updates - June 2024

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On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more

Venable LLP

FDA Approves First Interchangeable Biosimilar of Alexion’s Soliris® (eculizumab) - Amgen’s Bkemv™ (eculizumab-aeeb)

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On May 28, 2024, the FDA approved Amgen’s Bkemv™ (eculizumab-aeeb), the first interchangeable biosimilar of Alexion’s Soliris® (eculizumab).  Bkemv™ was approved with a skinny label for paroxysmal nocturnal hemoglobinuria...more

Venable LLP

Fresenius Kabi Announces FDA Acceptance of aBLA for Prolia® / Xgeva® (denosumab) Biosimilar Candidate FKS518

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On May 27, 2024, Fresenius Kabi announced the FDA acceptance of its aBLA for FKS518 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). ...more

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