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Hospira’s generic antibiotic Meropenem approved in US Generics/News | Posted 09/07/2010

On 22 June 2010, Hospira announced that it had received approval from the FDA for its generic antibiotic, Meropenem. This is the first generic launched in the antibiotic class and Hospira is the fi...

FDA ANDAs containing paragraph IV patent certifications Policies & Legislation | Posted 09/07/2010

In the US, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a pa...

Teva gains approval for generic breast cancer and anti-depressant drugs Generics/News | Posted 09/07/2010

The Israeli generics’ giant Teva Pharmaceuticals is racing ahead in the generics game with the announcement of the approval by the FDA of two new drugs for treatment of breast cancer and depression.

Bioequivalence testing for generics Generics/Research | Posted 08/07/2010

Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most generic drug formulations. In general, bioequivalence testing provides a use...

Russian drug spending set to reach US$4 billion by 2020 Policies & Legislation | Posted 07/07/2010

Russia is planning to pump RUB 120 billion (US$4 billion) into its fledgling pharmaceutical sector this decade as part of a broader push to diversify the economy away from its traditional oil and g...

Challenges in the development of biosimilars mAbs Biosimilars/Research | Posted 02/07/2010

What are the challenges facing development of biosimilar monoclonal antibodies (mAbs) in Europe? This was the question broached in a paper by Dr Christian Schneider – Chairman of both the Committee...

Development of biosimilars mAbs Biosimilars/Research | Posted 02/07/2010

Is the development of biosimilar monoclonal antibodies (mAbs) possible in Europe? This was the question broached in a paper by Dr Christian Schneider – Chairman of both the Committee for Advanced T...

Licensing of biosimilars in Europe Guidelines | Posted 02/07/2010

How is licensing of biosimilars actually being applied in Europe? This was the question broached in a paper by Dr Christian Schneider – Chairman of both the Committee for Advanced Therapies and Bio...