Biosimilars/News
Insulin glargine biosimilar gains South Korean approval
South Korea-based GC Pharma (formerly Green Cross Corporation) announced on 8 March 2018 that it had received approval for its insulin glargine biosimilar Glarzia from the Korean Ministry of Food and Drug Safety (MFDS).
Trastuzumab biosimilar launched in South Korea
South Korean pharmaceutical company Daewoong Pharmaceutical announced on 5 March 2018 that it had launched trastuzumab biosimilar Samfenet, developed by Samsung Bioepis, in South Korea.
EC approval for trastuzumab biosimilar Herzuma
South Korean biotechnology company Celltrion announced on 14 February 2018 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Herzuma (CT‑P6).
EMA approval for biosimilar insulin glargine Semglee
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 25 January 2018 that it had recommended granting marketing authorization for the insulin glargine biosimilar Semglee.
Denosumab biosimilar being developed in Australia
Australian biologicals company NeuClone disclosed on 5 January 2018 the fifth biosimilar candidate that the company is developing in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate for denosumab and is currently in preclinical development.
EC approval for bevacizumab biosimilar Mvasi
Biotech giant Amgen announced on 18 January 2018 that it had received European Commission (EC) approval for its biosimilar bevacizumab product Mvasi (ABP 215).
FDA accepts applications for adalimumab and trastuzumab biosimilars
Samsung Bioepis and Sandoz announced on 20 December 2017 and 16 January 2018, respectively, that the regulatory submissions for their proposed trastuzumab (SB3) and adalimumab (GP2017) biosimilars had been accepted by the US Food and Drug Administration (FDA).
EMA accepts application for pegfilgrastim biosimilar from USV
India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Medicines Agency (EMA).
Trastuzumab biosimilars receive EMA and ANVISA approval
Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.
FDA approves follow-on insulin lispro Admelog
Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).
