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EMA releases product-specific bioequivalence guidelines Guidelines | Posted 22/11/2013

The European Medicines Agency (EMA) announced on 15 November 2013 the release of the agency’s first product-specific guidance on the demonstration of bioequivalence for 16 active substances. The dr...

Sharing biosimilars substitution information with patients critical Biosimilars/Research | Posted 22/11/2013

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598. Some believed this bill would have impeded access to biosimilars, but others believe it would have supported...

Open-label studies show similarity of biosimilar infliximab and Remicade Biosimilars/Research | Posted 22/11/2013

The results of two open-label extension studies of Inflectra (CT-P13; infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, have confirmed the s...

FDA to allow generics makers to change labelling Policies & Legislation | Posted 22/11/2013

On 8 November 2013 the US Food and Drug Administration (FDA) announced that it had published its proposed rule allowing generics makers to change their labelling in the Federal Register.

Ireland high drug prices cannot be justified Pharma News | Posted 22/11/2013

The European Commission’s troika mission to Ireland has told Government TDs (Members of Parliament) that the cost of pharmaceutical drugs in the country cannot be justified. Drug prices in the coun...

FDA awards grant to study generic transplant drug tacrolimus Generics/Research | Posted 22/11/2013

The US Food and Drug Administration (FDA) has awarded a federal grant worth US$2.3 million to researchers at the University of Cincinnati, Ohio, USA, in order to continue studies into tacrolimus, a...

First generic 30 mg Focalin XR capsules approved Generics/News | Posted 22/11/2013

On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.

Price components of pharmaceutical expenditure Generics/Research | Posted 15/11/2013

In the second of a series of four articles on pharmaceutical expenditure, Vogler and co-authors take a top down approach to the concept of pharmaceutical expenditure and its use as an indicator in...