Biosimilars/News
EMA approval for trastuzumab biosimilar Kanjinti
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Kanjinti.
Insulin biosimilar Semglee gains EC and Australian approval
India-based Biocon and US-based partner Mylan announced on 28 March 2018 that they had received European Commission (EC) and Australian approval for their co-developed insulin glargine biosimilar, Semglee.
Trastuzumab biosimilar Ontruzant launched in the UK
Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada, announced on 8 March 2018 that it had launched the trastuzumab biosimilar, Ontruzant, in the UK.
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).
