Menu

Biosimilars/News

Question-Fimea-V15E29

FDA rejects trastuzumab and rituximab biosimilars

Biosimilars/News | Posted 04/05/2018

US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of its trastuzumab biosimilar. Then Sandoz, part of Novartis, announced on 2 May 2018 that its biosimilar rituximab application had also been rejected.

Cancer Cell V13I20

Australia approves rituximab biosimilar Truxima

Biosimilars/News | Posted 27/04/2018

South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima (CT‑P10).

18 AA010920

FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars

Biosimilars/News | Posted 20/04/2018

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.

Rheumatology.org V13H09

EMA approval for infliximab biosimilar Zessly

Biosimilars/News | Posted 13/04/2018

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.

Breast cancer V15J22

EMA approval for trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 06/04/2018

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.

Diabetes V14K06

Insulin biosimilar Semglee gains EC and Australian approval

Biosimilars/News | Posted 30/03/2018

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 Herceptin V13D12

Trastuzumab biosimilar Ontruzant launched in the UK

Biosimilars/News | Posted 23/03/2018

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.

25 AA011049

Insulin glargine biosimilar gains South Korean approval

Biosimilars/News | Posted 16/03/2018

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).

Breast cancer V15J22

Trastuzumab biosimilar launched in South Korea

Biosimilars/News | Posted 09/03/2018

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.

Cancer image015

EC approval for trastuzumab biosimilar Herzuma

Biosimilars/News | Posted 02/03/2018

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).