Biosimilars/News

Henlius makes deal with Getz Pharma for adalimumab copy biological

Biosimilars/News | Posted 01/04/2022

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 23 February 2022 that it had entered into a licensing and supply agreement with Pakistan-based Getz Pharma for its adalimumab copy biological, Handa Yuan (汉达远; HLX03).

Canada approves ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 25/03/2022

The ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received approval from Canada’s drug regulator, Health Canada, on 8 March 2022. This is the first ranibizumab biosimilar to receive approval in Canada.

FDA accepts application for interchangeability of adalimumab biosimilar Abrilada

Biosimilars/News | Posted 18/03/2022

US-based pharma giant Pfizer announced on 25 February 2022 that the US Food and Drug Administration (FDA) had accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).

Generium launches omalizumab (Xolair) non-originator in Russia

Biosimilars/News | Posted 11/03/2022

Moscow’s Generium has launched a non-originator biological of omalizumab (Xolair) on the Russian market, the third of Generium’s products using Selexis’ SUREtechnology Platform to reach the market.

EMA recommends approval of teriparatide and pegfilgrastim biosimilars

Biosimilars/News | Posted 18/02/2022

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

Biosimilars/News | Posted 11/02/2022

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

Biosimilars/News | Posted 04/02/2022

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

Biosimilars/News | Posted 28/01/2022

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

Biosimilars/News | Posted 21/01/2022

Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).

Canada approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 14/01/2022

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

Biosimilars/News | Posted 14/01/2022

Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.

Positive phase III results for omalizumab copy biological

Biosimilars/News | Posted 27/05/2016

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.