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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.

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).

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.

Trastuzumab similar biologic Hervycta launched in India

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 July 2018 the launch of its product Hervycta, a ‘similar biologic’ of trastuzumab, in India.

Mylan gains nod for Ogivri and launches Hulio in Europe

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced at its meeting on 18 October 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Ogivri.