On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed - As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan...more
Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more
Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. As we previously reported, the case was expedited, with...more
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European...more