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.