Biosimilars/News

Trastuzumab emtansine ‘similar biologic’ Ujvira launched in India

Biosimilars/News | Posted 11/06/2021

India-based generics manufacturer Zydus Cadila (Zydus) announced on 24 May 2021 the launch of its trastuzumab emtansine ‘similar biologic’ Ujvira in India. The launch, according to Zydus ‘marks the world’s first biosimilar antibody drug conjugate (ADC) of trastuzumab emtansine’. 

Clinical trials for aflibercept biosimilars

Biosimilars/News | 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.

Canada approves five adalimumab biosimilars in last six months

Biosimilars/News | 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

Biosimilars/News | 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

Biosimilars/News | 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

Biosimilars/News | 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

Biosimilars/News | 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

Biosimilars/News | 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.

Advances for Formycon and Alteogen’s eye disease biosimilar candidates

Biosimilars/News | Posted 16/04/2021

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

Biosimilars/News | Posted 09/04/2021

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.