News
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 »
EU guidelines for nanosimilars
2013-11-19 Last update: 5 November 2013 The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency… Read More »
WHO naming of biosimilars
2013-11-14 The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups, but criticized by others. The… Read More »
The future of nanomedicines – nanosimilars
2013-11-12 First there were generics, then came biosimilars and soon the European Medicines Agency (EMA) is anticipating the first nanosimilars, or similar versions of originator nanomedicines.… Read More »
California governor vetoes biosimilars bill
2013-11-08 On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598, a bill that some believed would have impeded access to biosimilars.… Read More »
