EMA’s CHMP Recommends Approval of Three Biosimilars

The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions, recommending the granting of marketing authorisation, for three biosimilar medicines:  (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio (adalimumab), a biosimilar of Humira® for the treatment of certain inflammatory and autoimmune disorders; (2) Accord Healthcare’s Pelgraz (pegfilgrastim) and (3) Coherus Biosciences’ Udenyca (pegfilgrastim), both biosimilars of Neulasta® for the reduction of the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

In a joint press release, Mylan and FKB stated that “[t]he decision of the European Commission (EC) on the approval is expected in October 2018, which would grant marketing authorization in the 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein” for Hulio.  As we previously reported, Mylan and FKB are collaborating to commercialize this biosimilar in Europe.

Accord also issued a press release in conjunction with the CHMP’s positive opinion, stating that “[o]nce approved, Pelgraz could be the first pegfilgrastim biosimilar to market in Europe indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy.” Quoting an Accord spokeperson, the press release further stated: “Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be a first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz.”

In addition, Coherus stated in a press release that “UDENYCA has the opportunity to become one of the first pegfilgrastim biosimilars to gain Marketing Authorization in Europe” and that “[t]he European Commission decision on the approval for UDENYCA is expected in October.”  Coherus also noted that “UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date expected on or before November 3, 2018.”