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 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 5, 2025, Amgen and Samsung Bioepis reached a settlement in Case No. 1:24-cv-08417 (D.N.J.) / 1:25-md-3138 (D.N.J.), and the Court entered a consent judgment. The litigation related to Samsung Bioepis’s Prolia® /...more
9/30/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Samsung ,
Settlement
On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta®...more
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
8/13/2025
/ Biocon ,
Biologics ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Teva Pharmaceuticals
On July 14, 2025, Fresenius Kabi filed IPR2025-01268 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) and IPR2025-01269 against U.S. Patent No. 10,828,345 (“the ’345 patent”), both relating to EYLEA®...more
8/4/2025
/ Biologics ,
Biosimilars ,
BPCIA ,
Fresenius ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more
8/1/2025
/ Amgen ,
Biosimilars ,
BPCIA ,
Bristol-Myers Squibb ,
Denial of Institution ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On July 16, 2025, Amgen and Accord settled Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) alleging infringement of 34 of Amgen’s patents by Accord’s proposed Prolia® / Xgeva® (denosumab) biosimilar INTP23...more
On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more
On June 2, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 against claims 1–12, 14–17, 19, 20, 22–36, 39–42, 44, 45, and...more
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
5/12/2025
/ aBLA ,
Biosimilars ,
BPCIA ,
Celltrion ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Fresenius ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Legislative Agendas ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
4/3/2025
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
FDA Approval ,
Healthcare ,
Medicare ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Proposed Legislation ,
Regulatory Requirements
On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On November 13, 2024, Amgen filed Case No. 5:24-cv-00642 (E.D.N.C.) against Accord BioPharma and Intas Pharmaceuticals, alleging INTP23, their proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 34 of Amgen’s...more
On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents....more
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
8/29/2024
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron ,
Sandoz
On May 28, 2024, Amgen filed a BPCIA litigation, Case No. 1:24-cv-06497 (D.N.J.), against Celltrion’s proposed Prolia® / Xgeva® (denosumab) biosimilar CT-P41 alleging infringement of 29 of Amgen’s patents, including one...more
On May 17, 2024, Regeneron filed a second infringement litigation against Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42, Case No. 1:24-cv-00053 (N.D.W. Va.). The aBLA for CT-P42 was submitted to the FDA in June...more
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more
4/18/2024
/ Biocon ,
BPCIA ,
Dismissals ,
Lack of Jurisdiction ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
3/15/2024
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579,...more
The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more
There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion’s proposed biosimilar CT-P42 filed on November 8, 2023, Case No....more