Mazumdar-Shaw, Chairman & Managing Director of Biocon, recently stated that Biocon is developing a portfolio of 10 biosimilars, and will continue to invest 12-15% of its revenue in research and development. According to Ms. Mazumdar-Shaw, Biocon’s biosimilars span insulin, monoclonal antibodies, and other recombinant proteins for markets in India and…
In its Q2 2017 Earnings Call last week, Momenta reported that it continues to work towards a first submission for approval of its wholly owned HUMIRA biosimilar, M923, with a possible commercial launch by 2020. Momenta also reported that it is looking for potential collaborators as it further develops M923. In…
The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for six of eight of Avastin’s indications. Mylan and Biocon’s Herceptin biosimilar candidate, MYL-1401O, was reviewed for all of Herceptin’s indications….
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila (Pegfilgrastim), Ogivri (Trastuzumab), and Semglee (Insulin Glargine). The French National Agency for Medicines and Health Products Safety (ANSM), on…
Mylan has filed two petitions for inter partes review of Sanofi’s patents related to insulin glargine: IPR2017-01526 on U.S. Patent 7,476,652, and IPR2017-01528 on U.S. Patent 7,713,930. Insulin glargine is marketed under the tradename Lantus®. As we have reported, both the ‘652 and ‘930 patents are the subject of litigation…
The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session, the…
Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized antibodies. The petitions do not identify a particular product that may use the patented methods. IPR petitions challenging the…
To view our full FDA Approvals tracking table, click here. Last updated: September 2, 2026
As we reported yesterday, Mylan announced that it has reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. relating to trastuzumab, which extended to Mylan agreeing to withdraw its IPR challenge to U.S. Pat. No. 6,331,415 (the ‘415 patent). Mylan and Genentech have now filed a joint motion to…
Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos. 6,407,213 and 6,331,415….