News
Cost savings from use of biosimilars in rheumatology
2013-12-24 The treatment of rheumatoid arthritis provides a clear argument in favour of developing biosimilars and the need to collect sufficient pharmacological data to validate their… Read More »
The cost of evergreening strategies
2013-12-19 The practice of evergreening, where pharmaceutical companies make small patentable changes to existing products with soon-to-expire patents, contributed to increased healthcare costs in Switzerland, according… Read More »
Interchangeability of gabapentin generic formulations in The Netherlands: summary of a comparative bioavailability study
2013-12-17 Abstract The registration of generic formulations in the EU is governed by regulatory authorities in the respective European countries. Before a generic drug can be registered,… Read More »
Australia issues new biosimilars guidance
2013-12-12 Australia’s regulatory body, the Therapeutic Goods Administration (TGA) published specific guidance for biosimilars on its website on 30 July 2013. The purpose of the guidance,… Read More »
India to make prescribing of generics compulsory
2013-12-10 A parliamentary panel is proposing that the Indian Government should bring in legislation that would make it compulsory for doctors to prescribe only low cost… Read More »
Authorized generics reduce drug prices
2013-12-05 In what seems to be a bit of a turnaround for the US Federal Trade Commission (FTC), the agency has released a report which suggests… Read More »
Celltrion applies for biosimilar infliximab approval in Japan
2013-12-03 On 11 September 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of Remsima, its biosimilar infliximab monoclonal antibody, with Japan’s… Read More »
Fight continues over biosimilar naming standards
2013-11-28 Biosimilar products marketed in the US should share the same common non-proprietary name as the reference brand-name biological medicine, according to the Generic Pharmaceutical Association… Read More »
Naming requirements in Australian biosimilars guidance
2013-11-26 Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance… Read More »
Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins
2013-11-21 Canada’s regulatory agency, Health Canada, is asking drugmakers seeking approval of similar drugs containing low molecular weight heparins (LMWHs) to use the approval pathway for… Read More »
