Biosimilars/News
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.
FDA reviews adalimumab biosimilar SB5
Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) had been accepted by the US Food and Drug Administration (FDA).
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).
