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WHO should finalize its BQ guidance Biosimilars/General | Posted 14/12/2018

According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will allow quick and accurate tracing of the man...

International promotion and education for biosimilars Reports | Posted 14/12/2018

International initiatives to promote the use of biosimilars and improve their understanding is just one of the subjects investigated by a report published by the Canadian Agency for Drugs and Techn...

British diabetologists issues position statement on biosimilar insulin Biosimilars/General | Posted 14/12/2018

The Association of British Clinical Diabetologists (ABCD) has issued a position statement on the use of biosimilar insulin. The statement summarises information on the advantages and disadvantages...

Biosimilars launched in the US at a significant discount Biosimilars/News | Posted 14/12/2018

Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.

Five more countries added to EU-US mutual recognition agreement Policies & Legislation | Posted 14/12/2018

The European Medicines Agency (EMA) announced on 29 November 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include five additional EU Member...

Positive results for adalimumab and etanercept biosimilars from Sandoz Biosimilars/Research | Posted 14/12/2018

On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etanercept biosimilars [1, 2].

Health care in Iraq saves money by incorporating off-patent biologicals Pharma News | Posted 14/12/2018

Iraq is one of many countries determined to increase its budget savings by replacing appropriate originator biologicals with off-patent biologicals. This is due to the recognition of the proven imp...

FDA approves drug for cancers with specific biomarker Generics/News | Posted 14/12/2018

The US Food and Drug Administration (FDA) announced on 26 November 2018 that it had approved Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific ge...