Biosimilars/News
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).
EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca
In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.
EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo
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
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
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.
Adalimumab and trastuzumab biosimilars gain EC approval
A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).
Japan approves first darbepoetin alfa biosimilar
Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosimilar.
Trastuzumab and Bevacizumab products approved in Australia and Argentina
Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.
