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FDA discredits study claiming foreign generics tainted Generics/General | Posted 11/04/2014

Research suggesting that foreign generics are inferior to US generics has been discredited by the FDA’s Center for Drug Evaluation and Research Director Dr Janet Woodcock.

Development of Iranian guidelines for ‘biogenerics’ Guidelines | Posted 11/04/2014

The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicin...

Australian price cuts make PBS affordable Policies & Legislation | Posted 11/04/2014

The price cuts for 121 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that represents originato...

Actavis buys Thai generics company Pharma News | Posted 11/04/2014

US generics major Actavis has acquired Silom Medical Company, a privately held generics firm focused on developing and marketing therapies in Thailand, for around US$100 million in cash.

Celltrion starts phase III biosimilar trastuzumab trial Biosimilars/News | Posted 11/04/2014

South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) in patients with human epidermal growth factor receptor 2-positi...

Taiwan TWi gains FDA approval for generic nifedipine Generics/News | Posted 11/04/2014

Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).

Cost savings to be made by switching to Zarzio Biosimilars/Research | Posted 04/04/2014

Since the first filgrastim biosimilar was approved in 2008, there is now five years of data on which to assess the efficacy, safety and cost-effectiveness of biosimilar granulocyte colony-stimulati...

Bill proposes extension of patents for new uses of biologicals Policies & Legislation | Posted 04/04/2014

A new bill, introduced in the US House of Representatives on 24 March 2014, proposes allowing patent owners to extend terms for certain biological patents if they are approved for new indications.