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FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars

South Korean biotechnology company Celltrion announced on 6 April 2018 that it had received complete response letters (CRLs) from the US Food and Drug Administration (FDA) regarding its candidate rituximab (CT‑P10) and trastuzumab (CT‑P6) biosimilars.

EMA approval for infliximab biosimilar Zessly

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 infliximab biosimilar Zessly.

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.