Posted by Michael Wonder on 29 Jul 2018
Coherus Biosciences receives positive CHMP opinion for Udencya (pegfilgrastim biosimilar candidate)
27 July 2018 - Coherus BioSciences today announced the CHMP of the EMA has adopted a positive opinion for the marketing authorization of Udencya (formerly CHS-1701), a pegfilgrastim (Neulasta) biosimilar candidate.
Udencya has the opportunity to become one of the first pegfilgrastim biosimilars to gain marketing authorisation in Europe.
Udencya’s marketing authorisation application to EMA is supported by analytical similarity data, a 3-arm, triple-crossover pharmacokinetic and pharmacodynamics study in healthy subjects, as well as a robust immunogenicity package including a dedicated immunogenicity study in over 300 subjects.
