Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe. Per the announcement, the agreement includes proposed…
Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. As we previously reported, Celltrion…
We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about Janssen seeking a preliminary injunction to block Amgen from the commercial manufacturing, sale, and offer for sale of its ustekinumab product. Briefing for the PI motion was…
The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs) and Post Grant Reviews (PGRs) by 25% “to improve cost recovery.” Additionally, the PTO is proposing to allow IPR and PGR petitions to exceed the current…
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once…
On March 20, 2023, Coya Therapeutics, Inc. (“Coya”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. COYA 302 is a dual biologic comprised of COYA 301 and…
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen…
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris. Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022. The CRL relates…
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to biosimilars, an American problem.”[1] The article, published in the Journal of Law and the Biosciences, examines whether patent…
Alvotech announced yesterday the initiation of a pharmacokinetic study for AVT05, a biosimilar referencing Johnson & Johnson’s (“J&J”) SIMPONI and SIMPONI ARIA (golimumab). SIMPONI is used to treat certain types of rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and ulcerative colitis (UC). The study will assess…