This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Start to Resolve As in 2023 and 2024, Regeneron’s multi-district…
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….
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…
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…
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…
As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh). A redacted version of the previously-sealed district court opinion was filed earlier this month. The…
Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. As we previously reported, HERCESSI was approved earlier…
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would…
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with…
In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation. The Court’s ruling on the permanent injunction follows a nine-day bench trial, held in June 2023, after which the Court held on December…