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Adalimumab copy biological accepted for review in China posted 15/11/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted...

Phase I trials started for aflibercept and ustekinumab biosimilars posted 15/11/2019

Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.South Korean biologicals company Alteogen...

22119008_l FDA approves pegfilgrastim biosimilar Ziextenzo posted 12/11/2019

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Dr...

Tanvex BioPharma’s filgrastim biosimilar comes under fire posted 12/11/2019

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infr...

20920796_l Bevacizumab ‘similar biologic’ Versavo launched in India posted 11/11/2019

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its b...

 

Research

Biologicals and biosimilar use in Asian patients with IBD posted 15/11/2019

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some As...

Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab posted 15/11/2019

A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). H...

Clinical data requirements for biosimilars in the EU: immunogenicity comparability posted 12/11/2019

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case s...

Biosimilars regulation in Canada: state of play posted 12/11/2019

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, i...

Clinical data requirements for biosimilars in the EU: efficacy comparability posted 11/11/2019

The European Medicines Agency (EMA) uses a totality of evidence approach in its regulatory review process for biosimilar appr...

 

General

Oncology pharmacists issue position statement on biosimilars posted 15/11/2019

On 4 October 2019, the International Society of Oncology Pharmacy Practitioners (ISOPP) issued their global position on the u...

Biosimilars approved in Japan posted 15/11/2019

Last update: 15 November 2019In Japan, the regulatory body for the approval of medicines, including biologicals, is the...

Biosimilars of adalimumab posted 15/11/2019

Last update: 15 November 2019Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tum...

Biosimilars approved in Canada posted 15/11/2019

Last update: 8 November 2019In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic...

Biosimilars of bevacizumab posted 15/11/2019

Last update: 8 November 2019Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new bl...

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