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.

Argentina approves bevacizumab similar biological medicine Zutrab

Biosimilars/News | 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

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).

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.