Regeneron is appealing a recent legal decision that allows Amgen to proceed with the US sales of Pavblu (aflibercept-ayyh), its biosimilar version of Regeneron's Eylea (aflibercept). The decision, made by a federal judge in West Virginia, has significant implications for Regeneron, as Eylea generated $5.89 billion in US sales in 2023.
Aflibercept Biosimilar Legal Battle
Regeneron had sought a preliminary injunction to block Amgen's biosimilar, Pavblu, alleging patent infringement. However, Judge Thomas Kleeh rejected the request, allowing Amgen to move forward with its launch plans. Regeneron's stock subsequently dropped by 4.6%. The company has announced its intention to appeal the decision. Amgen's Pavblu was approved by the FDA in September 2024 for retinal conditions. The legal battle is part of Regeneron's broader efforts to defend Eylea from biosimilar competition, which could significantly impact its market share.
Humira Biosimilars Expansion
Prime Therapeutics has announced new cost-effective biosimilar solutions for Humira (adalimumab), set to begin in 2025. Prime will recommend biosimilar options from Organon (Hadlima; adalimumab-bwwd), Teva (Simlandi; adalimumab-ryvk), Sandoz (unbranded adalimumab-adaz), and Celltrion (unbranded adalimumab-aaty). These biosimilars will be priced as low as $500 to $600 per 30-day supply. Prime is the latest pharmacy benefit manager (PBM) to increase accessibility to adalimumab biosimilars, joining companies like Smith Rx, Evernorth, CVS Caremark, and GoodRx.
Denosumab Biosimilar Regulatory Review
Alvotech and Teva Pharmaceuticals announced that both the FDA and EMA have accepted the marketing authorization application for AVT03, a biosimilar candidate to Prolia and Xgeva (denosumab). Prolia is used to treat osteoporosis in postmenopausal women and men at high risk of fractures, while Xgeva is prescribed to prevent bone complications in adults with advanced cancer that has spread to the bones. Alvotech aims to increase patient access to these treatments at potentially lower costs. In a pivotal study (AVT03-GL-C01) involving 532 postmenopausal women with osteoporosis, AVT03 demonstrated clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK). Two additional studies (AVT03-GL-P01 and AVT03-GL-P03) also met their primary endpoints, demonstrating comparable PK, safety, and tolerability of AVT03 to Prolia and Xgeva in healthy participants.
