On January 13, 2021, EVOQ announced a license and collaboration agreement with Amgen for the development of new drugs for autoimmune disorders. According to the press release, Amgen and EVOQ…
On January 13, 2021, EVOQ announced a license and collaboration agreement with Amgen for the development of new drugs for autoimmune disorders. According to the press release, Amgen and EVOQ…
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,…
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order: 1….
As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a…
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public…
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…
On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent. The EPO found invalid certain claims of…
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…
On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications: Adult…
Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for…