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Watson files ANDA for generic Beyaz Generics/News | Posted 17/02/2012

Watson Pharmaceuticals (Watson) announced on 10 February 2012 that it had filed an Abbreviated New Drug Application (ANDA) with FDA for a generic version of Bayer HealthCare’s (Bayer) leading oral...

Italian physicians’ negative attitude to generics Generics/General | Posted 17/02/2012

A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.

Sandoz submits ANDA for generic treprostinil Generics/News | Posted 17/02/2012

US drugmaker United Therapeutics announced on 6 February 2012 that it had received a Paragraph IV Certification Notice Letter from Sandoz, the generics division of Swiss-based drug giant Novartis....

Quality by design in biomanufacturing Biosimilars/General | Posted 17/02/2012

In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices [1].This replaces the previous 1987 version (updated 2004) and it is un...

EMA risk management plans may increase prescriber confidence in biosimilars Biosimilars/Research | Posted 10/02/2012

In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase presc...

EMA a step closer to implementing new pharmacovigilance rules Policies & Legislation | Posted 10/02/2012

In an attempt to enable better protection of public health, new pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010 [1]. It is now the job of...

Volume and sales of drugs on the shortages list in the US Reports | Posted 10/02/2012

Despite record numbers of drug shortages being reported in the US [1], on the whole, over the past five years the supply of these drugs to healthcare providers–hospitals, clinics, pharmacies–has in...

Registration of biosimilars in Europe and the US Biosimilars/Research | Posted 10/02/2012

Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration proces...