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Patient access to rituximab in emerging markets Biosimilars/Research | Posted 19/09/2014

A Pfizer-sponsored study looking at access to the oncology treatment rituximab has revealed that use of this important drug would increase across all therapy types and markets if a biosimilar was a...

Generics applications under review by EMA – August 2014 Generics/General | Posted 19/09/2014

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...

Biosimilars in emerging markets Reports | Posted 19/09/2014

Less strict or ‘relaxed’ regulatory requirements for biosimilars in some emerging markets are driving the proliferation of non-originator biologicals [1].

Cipla and S&D Pharma make generics deal for Czech Republic and Slovakia Pharma News | Posted 19/09/2014

India-based generics maker Cipla has partnered with S&D Pharma to launch affordable, high quality generics in the Czech Republic and Slovakia.

Regulating the safety of biosimilars Biosimilars/Research | Posted 12/09/2014

Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety assessment of biosimilars has been prepared to assist all those interested...

FDA debuts purple book for biologicals and interchangeable biosimilars Biosimilars/General | Posted 12/09/2014

On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Purple Book’, a new set of lists of licensed biological products and inter...

Pharma’s future in China and the US Generics/Research | Posted 12/09/2014

Although generics will increase their share of all prescriptions in China and the US over the next 10 years, economic and structural incentives for new drug invention and brand-name prescribing by...

European approval for biosimilar insulin Biosimilars/News | Posted 12/09/2014

Partners Eli Lilly and Boehringer Ingelheim, announced on 10 September 2014 that they had received European Commission (EC) approval for its biosimilar insulin glargine product Abasria (LY2963016),...