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Canada approves enoxaparin biosimilars Inclunox and Noromby posted 20/11/2020

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.

Innovent and Eli Lilly receive approval for rituximab copy biological in China posted 06/11/2020

Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NM...

Canada approves trastuzumab biosimilar Kanjinti posted 30/10/2020

Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second...

EMA accepts application for ranibizumab biosimilar from Samsung Bioepis posted 23/10/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agen...

China accepts application for bevacizumab copy biological posted 19/10/2020

The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a...

 

Research

Discontinuation following biosimilar switching in IBD patients posted 20/11/2020

Medical management of inflammatory bowel diseases (IBD) has significantly improved since the introduction of biological thera...

Global harmonization of GMP standards for biologicals posted 20/11/2020

Biopharmaceuticals are complex as their active pharmaceutical ingredient (API) is manufactured using living systems. In turn,...

A blueprint for biosimilar assessment without efficacy trials posted 20/11/2020

Comparative efficacy trials have played an important role in biosimilarity assessments. However, with recent technological ad...

Copy biological approvals in China, compared to the US and EU posted 20/11/2020

A review of copy biological approvals in China finds that 75% of approved monoclonal antibodies, fusion proteins and gra...

19646665_l Rationale for biosimilar assessment without efficacy trials posted 20/11/2020

An article published in Drug Discovery Today explores the necessity of the clinical efficacy trial in biosimilarity assessmen...

 

General

Switching V19A17 Alberta Biosimilars Initiative: switching policy updates in Canada posted 23/11/2020

The Alberta government in Canada has announced updates to the Alberta Biosimilars Initiative. 

Biosimilars of etanercept posted 23/11/2020

Last update: 20 November 2020 Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour...

Biosimilars of darbepoetin alfa posted 23/11/2020

Last update: 20 November 2020Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (incre...

Biosimilar advances for Celltrion Healthcare posted 20/11/2020

South Korea-based biotechnology company Celltrion Healthcare announced advances related to their infliximab, omalizumab and a...

GBMA publishes information resources on biosimilars for consumers and carers posted 20/11/2020

The Generic and Biosimilar Medicines Association (GBMA), the representative body of generic and biosimilar medicine suppliers...

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