Replies to post #198127 on Biotech Values

[DewDiligence]

CHRS—Immunogenicity study for Neulasta FoB hits primary endpoints:

http://finance.yahoo.com/news/coherus-announces-chs-1701-neulasta-210500782.html

This study assessed the immunogenicity of two sequential 6 mg subcutaneous doses of CHS-1701 compared with two sequential 6 mg subcutaneous doses of Neulasta. The primary outcome measures were based on testing for the development of neutralizing antibodies and determination of the percent difference between the test articles in anti-drug antibody (ADA) response… This study successfully met both pre-specified immunogenicity endpoints…

This immunogenicity study should not be confused with the Neulasta bioequivalence study that failed and required a redo (#msg-119053489). Both studies are necessary for regulatory approval.