CHMP backs Volibris, four biosimilars

EMEA's CHMP issued a positive opinion on an MAA from GlaxoSmithKline (LSE:GSK; NYSE:GSK) for Volibris ambrisentan to treat pulmonary arterial hypertension (PAH). GlaxoSmithKline gained rights to the selective endothelin A receptor antagonist from Myogen, now part of Gilead (NASDAQ:GILD). Gilead markets the drug as Letairis in the U.S. Gilead was off $1.67 to $43.93 on Thursday.

The agency issued positive opinions on MAAs for four biosimilar versions of filgrastim to treat neutropenia: Ratiograstim and Filgrastim ratiopharm from ratiopharm (Ulm, Germany); Biograstim from CT Arzneimittel (Berlin, Germany); and Tevagrastim from Teva (NASDAQ:TEVA). The agency said the four products have been shown to be similar to Neupogen filgrastim, a granulocyte-colony stimulating factor (G-CSF) from Amgen (NASDAQ:AMGN). ...