In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. ...more
11/17/2025
/ Biosimilars ,
Biotechnology ,
BPCIA ,
Clinical Trials ,
Draft Guidance ,
Expedited Approval Process ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Requirements
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
11/10/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Dr. Reddy’s Labs. ,
Food and Drug Administration (FDA) ,
Injunctions ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs
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
10/7/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Consent Order ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Samsung Bioepis ,
Settlement Agreements
On September 18 and 19, 2025, the Patent Trial and Appeals Board (“PTAB”) issued final written decisions for four inter partes review (“IPR”) challenges brought by Merck Sharp & Dohme LLC (“Merck”) against Johns Hopkins...more
10/7/2025
/ Healthcare ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Johns Hopkins ,
Life Sciences ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art
On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc. (“Biogen”) to pay Genentech, Inc. (“Genentech”) $88,348,123 in unpaid royalties plus interest. The parties...more
10/7/2025
/ Biogen Idec ,
Contract Disputes ,
Contract Interpretation ,
Genentech ,
Intellectual Property Litigation ,
Licenses ,
Life Sciences ,
Patent Litigation ,
Patent Royalties ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Royalties
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
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
9/25/2025
/ Affirmative Defenses ,
Amgen ,
Antitrust Injuries ,
Biosimilars ,
BPCIA ,
Counterclaims ,
Fraud ,
Inequitable Conduct ,
Laches ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Regeneron ,
Sherman Act ,
Unfair Competition
On September 17, 2025, Alvotech USA Inc. and Alvotech hf. (“Alvotech”) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (“the ‘036 patent”), assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). ...more
9/19/2025
/ Biologics ,
Biosimilars ,
Life Sciences ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prior Art ,
Regeneron
On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more
9/3/2025
/ Biologics ,
Biotechnology ,
Contract Negotiations ,
Contract Terms ,
EU ,
European Commission ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regeneron ,
Regulatory Authority ,
Supply Chain
On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna)...more
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
7/30/2025
/ aBLA ,
Biologics ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
License Agreements ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Teva Pharmaceuticals
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
7/24/2025
/ Amgen ,
Biosimilars ,
Case Consolidation ,
Consent Agreements ,
Intellectual Property Litigation ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement Agreements
Teva Pharmaceutical Industries Ltd. (“Teva”) and Shanghai Fosun Pharmaceutical (Group) Co. (“Fosun Pharma”) recently announced a partnership to accelerate the development of Teva’s TEV-56278, a novel fusion protein that uses...more
On May 15, 2025, a jury returned a verdict finding Amgen Inc. (“Amgen”) liable for antitrust violations and awarding Regeneron Pharmaceuticals, Inc. (“Regeneron”) over $400 million in damages....more
5/20/2025
/ Amgen ,
Antitrust Litigation ,
Antitrust Violations ,
Damages ,
Jury Verdicts ,
Monopolization ,
Pharmaceutical Industry ,
Regeneron ,
Sherman Act ,
The Clayton Act ,
Unfair Competition
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more
On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN®. JOBEVNE™ is a...more
On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®....more
On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are...more
On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding...more