News

Cost savings from use of biosimilars in rheumatology

Published on 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 bioequivalence and interch...

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The cost of evergreening strategies

Published on 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, a...

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Interchangeability of gabapentin generic formulations in The Netherlands: summary of a comparative bioavailability study

Published on 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, bioequivalence to the ...

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Australia issues new biosimilars guidance

Published on 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, according to the TGA...

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India to make prescribing of generics compulsory

Published on 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 generic drugs. The Parliamentary Standin...

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Authorized generics reduce drug prices

Published on 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 that authorized generics can reduce both retail and wholesale drug ...

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Celltrion applies for biosimilar infliximab approval in Japan

Published on 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 Ministry of Health...

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Fight continues over biosimilar naming standards

Published on 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 (GPhA). ...

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Naming requirements in Australian biosimilars guidance

Published on 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 is a section on ...

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Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins

Published on 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 subsequent entry bi...

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EU guidelines for nanosimilars

Published on 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 is responsible for the scientific evaluati...

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WHO naming of biosimilars

Published on 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 International Nonproprietary Name (INN) s...

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