Biosimilars/News
EMA recommends approval of teriparatide and pegfilgrastim biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that it had recommended granting of marketing authorization for the teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.
Lupin forms partnership to market pegfilgrastim biosimilar in Brazil
Indian multinational pharmaceutical company Lupin Ltd (Lupin) has signed an agreement with Brazilian firm Biomm SA to distribute and market a pegfilgrastim biosimilar in Brazil. In related news, Indian firm Gland Pharma has announced plans to enter the market for biosimilar manufacturing.
Applications for adalimumab and trastuzumab biosimilars submitted to FDA
Korea-based Samsung Bioepis and partner US-based Organon announced on 5 January 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5). A low-concentration formulation of SB5, Hadlima (adalimumab-bwwd), was approved in the US in July 2019 [1].
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.
