On December 18, 2025, the FDA approved Formycon and Zydus’s Nufymco™ (ranibizumab-leyk) as the third interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab). Lucentis® biosimilars have been on the market since July...more
On December 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On December 3, 2025, Fresenius Kabi and SamChunDang Pharm announced the FDA acceptance of their aBLA for SCD-411 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). Under their licensing agreement...more
1/9/2026
/ aBLA ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Fresenius ,
Inter Partes Review (IPR) Proceeding ,
License Agreements ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron ,
Settlement ,
Teva Pharmaceuticals
On December 2, 2025, Sarepta Therapeutics filed three petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations....more
On December 2, 2025, the Federal Circuit issued two related decisions concerning Seagen’s U.S. Patent No. 10,808,039 (“the ’039 patent”), asserted against Daiichi Sankyo and AstraZeneca in litigation over the antibody–drug...more
On November 20, 2025, the FDA approved Accord’s Osvyrti® and Jubereq® (denosumab-desu), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
12/9/2025
/ Amgen ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Injunctions ,
Intellectual Property Litigation ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On November 18, 2025, ToolGen, Inc. (“ToolGen”) filed a complaint (“Complaint”) in the District of Massachusetts alleging infringement of its U.S. Patent No. 12,473,559 (“the ’559 patent”) by Vertex Pharmaceuticals and...more
On November 25, 2025, Sarepta Therapeutics filed two petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations....more
On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat...more
On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same...more
On November 6, 2025, Amgen filed its eighth and ninth BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-17277 (D.N.J.) against Alvotech and Dr. Reddy’s AVT03 and Case No....more
11/20/2025
/ Amgen ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Multidistrict Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On November 6, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Sarepta Therapeutics’ IPR2025-01194 against claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent) and...more
On November 6, 2025, Hikma announced the U.S. launch of Starjemza™ (ustekinumab-hmny), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Starjemza™ is approved for all the reference product’s indications,...more
On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies”...more
11/10/2025
/ Biosimilars ,
Clinical Trials ,
Draft Guidance ,
Drug Pricing ,
Expedited Actions Process ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Guidance ,
Regulatory Requirements ,
Research and Development
On October 20, 2025, Celltrion and Regeneron announced they reached a settlement agreement, dismissing Case Nos. 1-23-cv-00089 (N.D.W. Va.) and 1-24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more
Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides,...more
10/27/2025
/ Biologics ,
Enablement Inquiries ,
Intellectual Property Litigation ,
Merck ,
Obviousness ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Written Descriptions
On October 1, 2025, the PTAB granted Amgen’s request for adverse judgment based on Bristol-Myers Squibb’s (“BMS”) statutory disclaimer of all challenged claims prior to institution of trial....more
10/27/2025
/ Amgen ,
Biosimilars ,
Bristol-Myers Squibb ,
Disclaimers ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Statutory Disclaimers ,
Statutory Interpretation ,
USPTO
On October 2, 2025, Celltrion launched Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). ...more
On October 9, 2025, Celltrion announced the FDA approved Eydenzelt® (aflibercept-boav), a biosimilar of Regeneron’s EYLEA® (aflibercept). ...more
On September 18, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00625 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,339,219 B2 (“the ’219...more
Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides,...more
On October 1, 2025, the FDA approved Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On September 30, 2025, Amgen and Biocon Biologics reached a settlement in Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). The litigation related to Biocon’s Prolia® / Xgeva® (denosumab) provisionally...more
10/8/2025
/ Amgen ,
Biocon ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Settlement
On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab)....more
10/8/2025
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genentech ,
Interchangeability ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On September 9, 2025, Sandoz announced it reached a settlement agreement with Regeneron, dismissing Case No. 1:24-cv-00085 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization...more