Biosimilars/News
Benepali gains approval for extra indications
Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 16 December 2016 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the extension of indications for its etanercept biosimilar Benepali
EMA accepts application for pegfilgrastim biosimilar from Coherus
US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval for its proposed pegfilgrastim biosimilar (CHS 1701) had been accepted by the European Medicines Agency (EMA).
Bevacizumab biosimilar application submitted to EMA
Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for approval for their proposed bevacizumab biosimilar (ABP 215) to the European Medicines Agency (EMA). The companies believe this submission is the first bevacizumab biosimilar application submitted to EMA.
Mylan and Biocon submit trastuzumab biosimilar to FDA
Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 8 November 2016 that they had submitted the marketing application for their proposed trastuzumab biosimilar (Myl-1401O) to the US Food and Drug Administration (FDA).
Teva and Celltrion to partner on biosimilars
Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.
Biosimilar rituximab approved in South Korea
South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rituximab biosimilar Truxima (CT-P10) from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).
Mylan and Biocon submit insulin glargine biosimilar to EMA
Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).
FDA accepts application for bevacizumab biosimilar
Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.
EMA approves biosimilars of insulin glargine and teriparatide
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.
Celltrion submits trastuzumab biosimilar application to EMA
South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to the European Medicines Agency (EMA).
