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Key issues for adalimumab biosimilars Biosimilars/Research | Posted 07/02/2020

Adalimumab is a popular and effective antibody treatment for inflammatory bowel disease (IBD). A recent position statement from the Belgian IBD research group (BIRD) reviews key issues surrounding...

EMA approval for rituximab biosimilar Ruxience Biosimilars/News | Posted 07/02/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab b...

Coherus signs licensing deal for bevacizumab biosimilar in the US Pharma News | Posted 07/02/2020

US-based Coherus BioSciences (Coherus) announced on 13 January 2020 that it had entered into a licensing agreement with Chinese biopharmaceutical firm Innovent Biologics (Innovent) for its bevacizu...

Failures when switching patients to biosimilar etanercept Biosimilars/Research | Posted 07/02/2020

A ‘real-world’ study on switching patients from the originator etanercept, Enbrel, to the biosimilar Benepali (SB4) investigated the reasons why some patients switched back to the originator [1].

Rituximab biosimilar ABP 798 submitted to FDA Biosimilars/News | Posted 07/02/2020

US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration...

New pricing system for drugs in Russia Policies & Legislation | Posted 07/02/2020

The Russian Government has passed a decree mandating ceiling prices for drugs on the country’s essential drugs list.

Japanese opportunity for biosimilars Reports | Posted 07/02/2020

Japan is proving to be a favourable market for biosimilars, with more than half a billion dollars worth in sales waiting for prospective makers of biosimilars.

Generics applications under review by EMA – January 2020 Generics/General | Posted 07/02/2020

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...