Biosimilars/News
Canada approves five adalimumab biosimilars in last six months
Since October 2020, Canada’s drug regulator, Health Canada, has approved no less than five adalimumab biosimilars for the treatment of multiple chronic inflammatory diseases.
Australia approves adalimumab biosimilar Abrilada
Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).
EC approves bevacizumab biosimilar Abevmy
On 26 April 2021, India-based biologicals specialist Biocon Biologics (Biocon) announced that its bevacizumab biosimilar, Abevmy (MYL 1402O), which it co-developed with US-based drugmaker Viatris (formerly Mylan), had received European Commission (EC) approval.
Samsung Bioepis launches Hadlima in Australia and Canada
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 29 March 2021 that it had now launched its adalimumab biosimilar, Hadlima (SB5), in Australia and Canada.
LG Chem gains approval for adalimumab biosimilar in Japan
Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).
EC approval for bevacizumab biosimilar Alymsys/Oyavas
The European Commission (EC) granted marketing authorization for the bevacizumab biosimilar Alymsys/Oyavas (MB02), on 31 March 2021. The biosimilar is developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.
Advances for Formycon and Alteogen’s eye disease biosimilar candidates
In March 2021, Formycon confirmed the resubmission strategy for their Lucentis® (ranibizumab) biosimilar candidate (FYB2010) in the US. In addition, Alteogen announced the completion of its phase I clinical trial of Eylea® (aflibercept) biosimilar (ALT-L9). Both of these biological drugs are used to treat conditions leading to the loss of vision.
FDA accepts application for adalimumab biosimilar CHS-1420
US-based Coherus BioSciences (Coherus) announced on 17 February 2021 that the US Food and Drug Administration (FDA) had accepted the application for their proposed adalimumab biosimilar CHS-1420.
EC approves adalimumab biosimilar Yuflyma
On 15 February 2021, South Korea-based biotechnology company Celltrion Healthcare (Celltrion) announced that its adalimumab biosimilar, Yuflyma (CT P17), had received European Commission (EC) approval.
EMA recommends approval of four bevacizumab biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 January 2021 that it had recommended granting marketing authorization for the bevacizumab biosimilars Alymsys and Oyavas. Then on 26 February 2021, the agency announced that it had recommended approval of the bevacizumab biosimilars Abevmy and Lextemy.
