News

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).

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.

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.

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.

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’.

The Argentina-based Richmond Laboratory (Laboratorios Richmond) announced on 19 March 2021 that it had gained approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) for its similar biological medicine (medicamento biológico similar) Zutrab (bevacizumab).

The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.

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.

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.

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 13 January 2021 that the investigational new drug (IND) application for its daratumumab copy biological, HLX15, had been accepted by China’s drug regulator, the National Medical Products Administration (NMPA), allowing it to carry out clinical trials in the country.