Biosimilares/Novedades

Clinical trials for aflibercept biosimilars

Biosimilares/Novedades | Posted 04/06/2021

Sandoz, the generics division of Novartis, has announced the start of a phase III clinical trial of its aflibercept (Eylea) biosimilar, a treatment for age-related macular degeneration. Clinical trials for a number of competitive biosimilars are also underway.

Argentina approves bevacizumab similar biological medicine Zutrab

Biosimilares/Novedades | Posted 26/03/2021

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).

FDA approves first interchangeable insulin glargine biosimilar

Biosimilares/Novedades | Posted 30/07/2021

In a landmark decision, the US Food and Drug Administration (FDA) has approved its first interchangeable biosimilar.

China approves sintilimab plus bevacizumab copy biological Byvasda

Biosimilares/Novedades | Posted 23/07/2021

China-based drugmaker Innovent Biologics (Innovent) announced on 29 June 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved the combination drug Tyvyt (sintilimab) plus bevacizumab copy biological Byvasda (IBI-305).

Canada approves five adalimumab biosimilars in last six months

Biosimilares/Novedades | Posted 31/05/2021

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

Biosimilares/Novedades | Posted 21/05/2021

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).

EC approves bevacizumab biosimilar Abevmy

Biosimilares/Novedades | Posted 14/05/2021

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

Biosimilares/Novedades | Posted 07/05/2021

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

Biosimilares/Novedades | Posted 30/04/2021

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

Biosimilares/Novedades | Posted 23/04/2021

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.