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EMA approval for bevacizumab biosimilar Zirabev

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.

Trastuzumab and agalsidase beta biosimilars launched in Japan

Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.

Biosimilars launched in the US at a significant discount

Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.

FDA approves first rituximab biosimilar Truxima

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).

Tanvex BioPharma submits filgrastim biosimilar to FDA

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.

Insulin glargine biosimilars launched in UK and South Korea

November 2018 has seen the launch of insulin glargine biosimilars in both the UK and South Korea.

Another adalimumab copy biological accepted for review in China

The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from Innovent Biologics (Innovent).

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA

Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA).

FDA approves adalimumab and pegfilgrastim biosimilars

The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab and pegfilgrastim biosimilars, respectively.

Adalimumab biosimilars Amgevita and Imraldi launched in Europe

In October 2018, two adalimumab biosimilars have been launched in the European Union (EU). Amgen announced the European launch of its adalimumab biosimilar, Amgevita and Biogen announced the launch of its adalimumab biosimilar Imraldi.