Biosimilars/News

FDA approves first interchangeable insulin glargine biosimilar

Biosimilars/News | 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

Biosimilars/News | 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).

EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 16/07/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen.

Canada approves rituximab biosimilar Riabni

Biosimilars/News | Posted 09/07/2021

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Canada approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 02/07/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

FDA accepts application for Lupin’s pegfilgrastim biosimilar

Biosimilars/News | Posted 21/06/2021

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 2 June 2021 that the US Food and Drug Administration (FDA) had accepted the application for approval for its proposed pegfilgrastim biosimilar.

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).