Biosimilars/News
FDA advisors recommend approval of Sandoz’s etanercept biosimilar
US Food and Drug Administration’s (FDA) advisors have voted to recommend the approval of Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).
Health Canada approves Inflectra biosimilar for extra indications
US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s medicines regulator, Health Canada, in three extra indications.
Alvogen opening biosimilars plant in Iceland
Iceland-based biopharmaceutical company Alvotech, a sister company of US generics company Alvogen, is set to open its state-of-the-art 11,800 square meter development and manufacturing facility for biosimilars in June 2016.
Rituximab biosimilar from Sandoz accepted for review by EMA
Sandoz, the generics division of Novartis, announced on 24 May 2016 that its regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the European Medicines Agency (EMA).
Samsung Bioepis infliximab biosimilar accepted for review by FDA
Samsung Bioepis (a Biogen and Samsung joint venture) and Merck announced on 24 May 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis for the companies’ infliximab biosimilar candidate, SB2.
Samsung Bioepis to launch infliximab biosimilar in South Korea
Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in South Korea.
Samsung Bioepis starts phase III trial for bevacizumab biosimilar
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis has started a phase III clinical trial for a biosimilar version of Roche’s cancer blockbuster Avastin (bevacizumab).
New administration route for epoetin alfa biosimilar Binocrit
Sandoz, the generics division of Novartis, announced on 8 April 2016 that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (SC) route of administration for its epoetin alfa biosimilar Binocrit’s nephrology (kidney function) indication.
Korean approval for infliximab biosimilar
Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).
EMA recommends approval of etanercept biosimilar
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 November 2015 that it had recommended granting of marketing authorization for a biosimilar etanercept product (SB4).
