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 15, 2025, the FDA approved Biocon’s Kirsty™ (insulin aspart-xjhz) as the first interchangeable biosimilar of Novo Nordisk’s NovoLog® (insulin aspart). ...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
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
7/15/2025
/ Biosimilars ,
Drug Pricing ,
FDA Approval ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
7/15/2025
/ Biosimilars ,
FDA Approval ,
Inter Partes Review (IPR) Proceeding ,
Litigation Strategies ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Requirements
In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...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 April 14, 2025, Celltrion announced that the FDA designated Yuflyma® (adalimumab-aaty) as an interchangeable biosimilar of AbbVie’s Humira® (adalimumab). Yuflyma® is a high-concentration (100mg/mL) citrate-free...more
On April 10, 2025, Biocon announced the FDA approval of Jobevne™ (bevacizumab-nwgd) as the sixth biosimilar of Genentech’s Avastin® (bevacizumab)...more
On March 18, 2025, Alvotech and Dr. Reddy’s announced the FDA acceptance of an aBLA for AVT03 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). Under their agreement, Alvotech is responsible for the...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
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 March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more
On February 28, 2025, the FDA approved Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) as the third company to receive FDA approval of biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
3/18/2025
/ Amgen ,
Biosimilars ,
Celltrion ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz
On March 7, 2025, the FDA approved Celltrion’s Omlyclo® (omalizumab-igec), the first interchangeable biosimilar of Genentech’s Xolair® (omalizumab). Omlyclo® was approved for all of Xolair®’s approved indications, including...more
On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...more
3/5/2025
/ Amgen ,
Biosimilars ,
FDA Approval ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On February 14, 2025, the FDA approved Sanofi’s Merilog™ / Merilog SoloStar® (insulin aspart-szjj), the first biosimilar of Novo Nordisk’s NovoLog® (insulin aspart). Merilog™ is packaged in a multi-dose vial, and Merilog...more
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 January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...more
2/17/2025
/ Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement...more
1/8/2025
/ Biosimilars ,
Celltrion ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Johnson & Johnson ,
Life Sciences ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement
On December 12, 2024, Gedeon Richter and Hikma announced the FDA acceptance of their aBLA for RGB-14 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)....more
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
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 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
Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more
8/27/2024
/ Biosimilars ,
Chevron Deference ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Inter Partes Review (IPR) Proceeding ,
Loper Bright Enterprises v Raimondo ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book
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