COHERUS BIOSCIENCES, INC. (NASDAQ:CHRS) Files An 8-K Other Events

ME Staff 8-k
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COHERUS BIOSCIENCES, INC. (NASDAQ:CHRS) Files An 8-K Other Events
Item 8.01 Other Events

In light of recent events, such as regulatory actions impacting other biologics developers with respect to their selected fill and finish facilities, Coherus BioSciences, Inc. (the “Company”) has determined that it is prudent to put into place an alternative fill and finish vendor to support the Company’s adalimumab (Humira®) biosimilar candidate CHS-1420’s Biologics License Application (“BLA”) filing. This change will move the projected filing timing for the CHS-1420 BLA to the first half of 2018. The Company has identified other vendors it believes can successfully meet the appropriate regulatory standards and scrutiny. Notwithstanding the delay, the Company believes this de-risking decision will enhance the long-term prospects of gaining approval within the standard review cycle, thereby avoiding post-review delays which would be costlier in the long run.

The Company plans to leverage the additional time to further advance its legal strategy and formulation development efforts for CHS-1420.


About COHERUS BIOSCIENCES, INC. (NASDAQ:CHRS)

Coherus BioSciences, Inc. is a late-stage clinical biologics platform company. The Company is focused on the global biosimilar market. The Company operates through developing and commercializing biosimilar products segment. Its business is organized around therapeutic franchises, including Oncology biosimilar candidates pegfilgrastim (Neulasta), in late clinical-stage, and bevacizumab (Avastin), in preclinical-stage; Immunology (Anti-TNF) biosimilar candidates, etanercept (Enbrel) and adalimumab (Humira), which are both in late clinical-stage; Ophthalmology biosimilar candidate ranibizumab (Lucentis) in preclinical stage, and Multiple sclerosis small molecule therapeutic candidate, CHS-131 (formerly INT-131), in Phase II proof-of-concept trial. Its long-acting granulocyte colony-stimulating factor (G-CSF) product candidate, CHS-1701, is a pegfilgrastim (Neulasta) biosimilar. Its clinical-stage pipeline consists of two anti-Tumor Necrosis Factors (anti-TNFs).