Biosimilars/News
FDA rejects pegfilgrastim biosimilar from Coherus
Coherus BioSciences (Coherus) announced on 12 June 2017 that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its candidate pegfilgrastim biosimilar, CHS‑1701.
EMA approval for adalimumab biosimilar Imraldi
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Imraldi from Samsung Bioepis.
Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA
Sandoz, the generics division of Novartis, announced on 31 May 2017 that the regulatory submissions for its proposed adalimumab (GP2017) and infliximab (PF‑06438179) biosimilars had been accepted by the European Medicines Agency (EMA).
EC approval for rituximab biosimilar Rixathon
Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval for its biosimilar rituximab product Rixathon.
FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar
US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).
Celltrion making progress with biosimilars in China and Japan
South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.
FDA advisory committee to review bevacizumab and trastuzumab biosimilars
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice on 7 June 2017 that it would be reviewing bevacizumab and trastuzumab biosimilars at its next meeting.
EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics
Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).
EMA approval for insulin and rituximab biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sanofi and for the rituximab biosimilars Blitzima, Ritemvia and Tuxella.
Positive phase I results for Cinfa’s pegfilgrastim biosimilar
Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 17 May 2017 that results from the second phase I study of its pegfilgrastim biosimilar (B12019) had met its primary endpoints.
