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...

6 views

Read more →

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...

12 views

Read more →

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 ...

67 views

Read more →

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...

2 views

Read more →

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...

6 views

Read more →

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 ...

5 views

Read more →

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...

10 views

Read more →

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). ...

44 views

Read more →

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 ...

7 views

Read more →

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...

6 views

Read more →

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...

49 views

Read more →

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...

9 views

Read more →