Biosimilars/News

EMA recommends approval of trastuzumab biosimilar Zercepac

Biosimilars/News | Posted 05/06/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 May 2020 that it had recommended granting of marketing authorization for a biosimilar trastuzumab product.

Teva launches rituximab biosimilar Truxima in US

Biosimilars/News | Posted 05/06/2020

Israeli generics giant Teva Pharmaceutical Industries (Teva) and partner, South Korean biotechnology company Celltrion, announced on 4 May 2020 that they had launched their rituximab biosimilar Truxima (TL011) in the US.

Trials of ustekinumab biosimilars advance

Biosimilars/News | Posted 29/05/2020

Japan-based Meiji Seika Pharma, together with the South Korean company Dong-A, have begun a phase I trial for their ustekinumab biosimilar. Meanwhile, the Australian firm NeuClone has reported results from the phase I trial of its ustekinumab biosimilar, NeuLara.

Canada approves rituximab biosimilars Riximyo and Ruxience

Biosimilars/News | Posted 22/05/2020

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

EMA recommends approval of Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 15/05/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 30 April 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Pegfilgrastim biosimilar Fulphila launched in Canada

Biosimilars/News | Posted 08/05/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

Celltrion files application with EMA for adalimumab biosimilar

Biosimilars/News | Posted 08/05/2020

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia

Biosimilars/News | Posted 04/05/2020

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Merck launches trastuzumab biosimilar in the US

Biosimilars/News | Posted 24/04/2020

US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastuzumab biosimilar, Ontruzant, in the US.

EC approval for rituximab biosimilar Ruxience

Biosimilars/News | Posted 24/04/2020

On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.