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CKD Pharma’s darbepoetin alfa biosimilar launched in Japan

On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).

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 agalsidase beta and trastuzumab 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).

EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.

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.

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.

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).

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.