Coherus announced completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a complete response letter from FDA for CHS-1701’s biologic license application (BLA) and it anticipates resubmitting the BLA in the U.S. at the end of the fourth quarter of 2017.
Coherus’ adalimumab biosimilar candidate CHS-1420 received decisions from the Patent Trial and Appeal Board of the United States Patent and Trademark Office (“PTAB”) in favor of Coherus’ petition for Inter Partes Review invalidating all of the claims of AbbVie’s U.S. Patents 8,889,135; 9,017,680 and 9,073,987. Coherus anticipates a BLA submission in the U.S. during the first half of 2018.
For its etanercept biosimilar CHS-0214, Coherus reported that it will be focusing on U.S. legal and regulatory issues through the first half of 2018. Also as part of its immunology (anti-TNF) therapeutic franchise, Coherus reported that it is completing additional animal studies on CHS-131 to further validate mechanism of action and address drug-derived metabolites. A CHS-131 Licensing agreement is due to follow subject to these results.