Cinfa Biotech Announces Positive Clinical Trial Results for Neulasta Biosimilar

gloved hand withdraws drug solution with syringe

Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the company’s press release, the trial demonstrates that Cinfa Biotech’s biosimilar is comparable to Amgen’s Neulasta in terms of pharmacodynamics, immunogenicity, and safety.  Cinfa Biotech’s announcement comes shortly after Novartis and Sandoz withdrew Sanodz’s application to the EMA for its Neulasta Biosimilar. Cinfa Biotech’s Managing Director stated that based on the data package for Cinfa Biotech’s biosimilar, the company is preparing to submit for EU approval in the second half of 2017.