Search Results for:

Biosimilar Clinical Trial Updates

Earlier this month, Clover Biopharmaceuticals, Celltrion, and JHL Biotech provided updates on their respective biosimilar clinical trials.  A summary of these developments is below. Clover Biopharmaceuticals announced the beginning of their Phase 1 trial of SCB-808, a proposed biosimilar to Enbrel (etanercept).  According to Clover, the trial is designed to…

Read More

STADA Acquires Majority Stake in Epoetin Biosimilar Licensor BIOCEUTICALS

On August 6, 2018, STADA Arzneimittel AG (“STADA”) announced that it had acquired a majority stake in BIOCEUTICALS Arzneimittel AG (“BIOCEUTICALS”).  According to the press release, STADA is acquiring an additional 35.48 percent of the shares in BIOCEUTICALS  from its co-shareholders to bring its total stake to 51.34 percent.  BIOCEUTICALS…

Read More

New BPCIA Complaint: Amgen Sues Apotex, Again, over Proposed Pegfilgrastim and Filgrastim Biosimilars

Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems.  According to…

Read More

IGBA Urges FDA to Waive the Requirement for Bridging Studies for Biosimilar Sponsors

In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required…

Read More