Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On November 6, 2025, Amgen, Inc. (“Amgen”) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy’s Laboratories (“Dr....more
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
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
On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Samsung Bioepis Co., Ltd. and...more
On September 30, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part the Motion to Dismiss filed by Amgen, Inc. and Immunex Corporation (“Amgen”) in a class action antitrust lawsuit...more
The Supreme Court in Amgen v. Sanofi affirmed the invalidation of Amgen's antibody patents for lack of enablement. The patents at issue claimed "the entire genus" of antibodies capable of (1) binding specific amino acid...more
The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the Biologics Price...more
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
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”)....more
On July 24, 2025, Acting Director of the USPTO, Coke Morgan Stewart, denied institution of inter partes review in IPR2025-00601 and IPR2025-00602, but referred the petition in IPR2025-00603 to the Board in Amgen Inc. v....more
Pegfilgrastim 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
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
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
Adalimumab 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 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
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 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...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
On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...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
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. ...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 June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099...more
The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the...more