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…
Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700…
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 July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.” The recalled product is not the branded SEMGLEE® pen, but rather the unbranded…
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…
The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more time to inspect the manufacturing facility. Such an inspection, which is a required step of the…
Last week, Biocon Ltd announced the approval of approximately a 150 million USD capital injection from Goldman Sachs. Dr. Christian Hamacher, CEO, Biocon Biologics, said, “This capital injection by Goldman Sachs will enable us to make prudent investments in R&D, high-quality manufacturing, as well as, establish a global commercial footprint.” …
Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue. It reported the following YoY revenue for each…
We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection). Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market. SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product. SEMGLEE will be available in vials and pre-filled pens. The lead…
On August 10, 2020, Equillium, Inc. announced its interim data for its study of itolizumab as a first-line treatment in patients with acute graft-versus-host disease (GVHD). GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants, and is the leading cause of non-relapse mortality…