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EMA regulatory guidance update to prepare for Brexit Guidelines | Posted 26/01/2018

In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guida...

EC workshop aims to improve access to biosimilars Reports | Posted 19/01/2018

With the aim of encouraging equitable and timely access to biosimilars in Europe, the European Commission (EC) held its third workshop on biosimilars in Brussels, Belgium on 5 May 2017 [1].

Biosimilars applications under review by EMA – January 2018 Biosimilars/General | Posted 19/01/2018

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval...

Additional clinical data for Cinfa’s pegfilgrastim biosimilar Biosimilars/Research | Posted 19/01/2018

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).

Treatment of chronic myeloid leukaemia patients with generic imatinib in Algeria Generics/Research | Posted 19/01/2018

In a developing country like Algeria expensive therapies are not available. Alternative approaches are needed. In Algeria Imatib (imatinib: CIPLA-India) was introduced in 2006; however, no study ha...

FDA approves follow-on insulin lispro Admelog Biosimilars/News | Posted 19/01/2018

Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).

France fines J&J 25 million Euro for blocking generics Generics/General | Posted 19/01/2018

A fine of Euros 25 million was imposed on Janssen-Cilag and its parent company Johnson & Johnson (J&J) by the French Competition Authority on 20 December 2017. This occurred in response to...

Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies Generics/News | Posted 19/01/2018

On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbreviated new drug applications (ANDAs) for generic versions of Advair Disku...