On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…
On May 19, 2022, Viatris Inc. and Biocon Biologics Ltd. announced that ABEVMY, a bevacizumab biosimilar, is now available in Canada. According to the press release, Viatris and Biocon Biologics co-developed ABEVMY, which references Roche’s AVASTIN (bevacizumab), a recombinant humanized monoclonal antibody that selectively binds to human vascular endothelial growth…
On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. SEMGLEE (insulin glargine-yfgn) injection launched last year in the U.S. as the first-ever interchangeable biosimilar approved…
On March 1, 2021, Formycon announced that it plans to resubmit its BLA for its Lucentis® Biosimilar Candidate FBY201 (ranibizumab) in the first half of 2021. Formycon expects to submit its application to the EMA soon thereafter, and will also seek approval in Canada, Australia, the United Kingdom and Switzerland….
Biocon Biologics, a subsidiary of Biocon, announced today that it has signed an agreement with Clinton Health Access Initiative (CHAI) to develop advanced cancer therapies for patients in 25 countries in Africa and 5 countries in Asia as part of the Cancer Access Partnership (CAP). According to the announcement, Biocon Biologics aims…