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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.

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’.

Argentina approves bevacizumab similar biological medicine Zutrab

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).

EC approval for insulin aspart biosimilar Kixelle

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.

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.

China accepts IND application for daratumumab copy biological HLX15

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.

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