Coherus announces CHS-1701 (Neulasta biosimilar) met primary endpoints in immunogenicity study

February 2, 2016 9:18 PM

Coherus Biosciences, Inc. announced that CHS-1701, a proposed biosimilar of Neulasta (pegfilgrastim), met both primary endpoints in a double-blind, randomized, two-period, parallel-arm clinical study in 303 healthy subjects.

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. First, no neutralizing antibodies were detected in either group. Second, the percent difference in ADA response between the test articles fell within the pre-specified success criteria for biosimilarity,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “Further, there were no clinically meaningful differences in the safety profiles of the two products.”

“The success of this rigorous study is a key achievement in support of our planned Biologics License Application (BLA) filing,“ said Denny Lanfear, President and Chief Executive Officer of Coherus. “To the best of our knowledge, we will be the only biosimilar company to have comparative immunogenicity data with Neulasta in a healthy population with an intact immune system. As the lead asset of our oncology therapeutic franchise, CHS-1701 will spearhead our commercialization efforts for oncology biosimilars in the United States. We expect to complete our follow-on PK/PD study for this product late in the first half of this year and move forward with BLA filing directly thereafter.”

 

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