News
FDA discredits study claiming foreign generics tainted
2014-11-27 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… Read More »
WHO investigates use of a biological qualifier for biosimilars
2014-11-25 The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th… Read More »
The generics market in China
2014-11-21 Market access barriers remain the main challenge for generics in China, according to a presentation by Xianghong Shao given at the International Generic Pharmaceutical Alliance… Read More »
US FTC hopes to collect US$1 billion from pay-for-delay settlement
2014-11-19 The US Federal Trade Commission (FTC) is looking to collect more than US$1 billion from a settlement with pharmaceutical companies it has sued for their… Read More »
Cost savings and use of generics in Europe
2014-11-17 Generics provide significant savings for the healthcare systems, as well as increased access to medicines, in the European Union (EU). This is according to a… Read More »
Bill proposes extension of patents for new uses of biologicals
2014-11-13 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… Read More »
Cost savings to be made by switching to Zarzio
2014-11-11 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… Read More »
Anticompetitive practices come under scrutiny in Australia
2014-11-07 The Australian Competition and Consumer Commission (ACCC) has started proceedings in the Federal Court against Pfizer Australia (Pfizer) alleging that offers made by Pfizer to… Read More »
EMA issues concept paper for revision of immunogenicity guideline
2014-11-05 On 25 March 2013 the European Medicines Agency (EMA) announced the publication of a concept paper to discuss the revision of the guideline on immunogenicity… Read More »
Indiana biosimilars substitution bill becomes law
2014-11-03 Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration… Read More »
