Biosimilars/News
FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar
The US Food and Drug Administration (FDA) has approved the adalimumab biosimilar Yusimry (adalimumab-aqvh) and the insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) [1].
Canada approves adalimumab biosimilars Simlandi and Yuflyma
Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).
Canada approves filgrastim biosimilar Nypozi
Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.
Etanercept biosimilars delayed until 2029 in US
Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.
Positive phase III results for omalizumab copy biological
US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had successfully completed a combined phase II and III clinical trial in China for STI-004, a copy biological for omalizumab (Xolair). STI 004 met its primary endpoint in a multicentre, randomized, double-blind, placebo-controlled, clinical study.
New Zealand announces funding for adalimumab biosimilar
New Zealand has announced that, in order to widen access to adalimumab, it will now fund the adalimumab biosimilar Amgevita.
China approves three bevacizumab copy biologicals
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved three bevacizumab.
Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea
South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.
Adalimumab biosimilar launched in Japan
Japan-based Mochida Pharmaceutical (Mochida) announced on 25 November 2021 that its adalimumab biosimilar had been launched in Japan following the listing of the drug on the National Health Insurance (NHI).
Australian and Indian approval for teriparatide products
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and the Drug Controller General of India (DCGI) has approved a teriparatide ‘similar biologic’.
