European Biosimilar Approval Updates: Adalimumab, Pegfilgrastim

In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the  European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines:  (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim), a proposed biosimilar of Neulasta®; and (3) Coherus Biosciences’  UDENYCA™ (pegfilgrastim), which is also a proposed biosimilar of Neulasta®.

In the past week, all three biosimilars received marketing authorization from the European Commission (EC):

  • Mylan and FKB announced that they received European marketing authorization for Hulio®(adalimumab). Mylan states that it plans to launch Hulio® across various European markets on or after October 16th
  • Coherus BioSiences announced that it received European marketing authorization for UDENYCA™ (pegfilgrastim).
  • Accord Healthcare announced that it received approval for Pelgraz® (pegfilgrastim).  In the press release, Accord’s Vice President of Specialty Brands, Europe/Middle East/North Africa Regions, said that Accord “anticipate[s] being first out of production and into the healthcare professional’s hands in most European markets.”


In addition, on September 21, 2018, the EMA published highlights from its September 17-20, 2018 CHMP meeting, reporting that the CHMP recommended the approval of three other pegfilgrastim biosimilars:  Mylan’s Fulphila , Cinfa Biotech S.L.’s Pelmeg and Sandoz’s Ziextenzo.