As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands. Celltrion also plans to launch STEQEYMA in Finland in mid-November, and in Ireland later in the month. STEQEYMA is the third ustekinumab…
On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). Under the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the…
On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further strengthening the pair’s alliance announced earlier in April of this year. For mAbxience, “this second collaboration is a testament to…
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines. According to the FTC, “PBMs are at the center of the complex pharmaceutical distribution chain that delivers a wide…
As Big Molecule Watch continues to push past the bounds of biosimilars and into biologics, we are proud to announce the publication of two additional trackers concerning vaccines: the Vaccine Patent Litigation tracker and the Vaccine Patent PTAB tracker. These resources are dedicated to detailing the ever-changing landscape of patent…
The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a budget-neutral provision for allowing biosimilar substitution without a separate determination…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
On November 14, 2023, in the third webinar in Goodwin’s 2023 Biosimilars Webinar Series, Goodwin IP Litigation partner and managing editor of the Goodwin PTAB Trial Tracker newsletter, Linnea Cipriano, Goodwin IP Litigation associate and Big Molecule Watch editor, James Breen and Goodwin IP Litigation associate, Christine Potkay, will provide…
The world of biosimilar litigation is back in full swing with several BPCIA lawsuits currently pending. On October 12, 2023, in the second webinar in Goodwin’s 2023 Biosimilars Webinar Series, Goodwin IP Litigation partner and BMW Founding Editor, Elaine Blais, Goodwin IP Litigation partner and BMW Editor-in-Chief, Natasha Daughtrey and…
Today, the Nobel Assembly at Karolinska Institutet announced that the Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman “for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA [messenger RNA] vaccines against COVID-19.” Dr. Karikó is a Professor at Szeged University and…