Biosimilars/News

Trastuzumab similar biologic Hervycta launched in India

Biosimilars/News | Posted 02/11/2018

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

Biosimilars/News | Posted 26/10/2018

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

Biosimilars/News | Posted 26/10/2018

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

Biosimilars/News | Posted 12/10/2018

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).

EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca

Biosimilars/News | Posted 05/10/2018

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo

Biosimilars/News | Posted 28/09/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 September 2018 that it had recommended granting of marketing authorizations for the pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo.

Adalimumab copy biologicals accepted for review in China

Biosimilars/News | Posted 28/09/2018

China Food and Drug Administration (CFDA) has accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera).

FDA advisers recommend approval of rituximab biosimilar CT-P10

Biosimilars/News | Posted 19/10/2018

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for CT‑P10, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). If approved by FDA, this would be the first rituximab biosimilar approved in the US.