On December 13, 2025, Biocon Biologics Ltd. (“Biocon”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into a license and settlement agreement to dismiss all pending claims in the parties’ disputes over Biocon’s aflibercept biosimilar, YESAFILI® (aflibercept-jbvf) in Europe and the rest of the world, following an earlier settlement covering the United…
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential…
On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however, there are a number of district court actions against other parties related to the patents challenged in Fresenius’s IPRs….
Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates. The two candidates, VEVZUO and Denosumab BBL (the brand name is currently under approval), are each intended for distinct therapeutic indications. According…
On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re: Aflibercept Patent Litigation (MDL No.: 1:24-md-3103). The stipulation had been filed the day before by Plaintiff…
On February 14, 2025, the U.S. Food and Drug Administration (“FDA”) approved Sanofi-Aventis U.S. LLC’s (“Sanofi”) MERILOG™ (insulin-aspart-szjj), a biosimilar to Novo Nordisk A/S’s (“Novo Nordisk”) NOVOLOG® (insulin aspart), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. MERILOG™ helps to lower mealtime spikes in…
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Amgen’s PAVBLU and SKOJOY, and CuraTeQ Biologics’ DYRUPEG. Amgen’s PAVBLU and SKOJOY, both biosimilars referencing EYLEA…
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the…
J.P Morgan states that the JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community”. On January 15, 2025, Goodwin and KPMG will host their…
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024. 1. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (“BLAs”), including for Autolus Inc.’s AUCATZYL…