News

Biosimilars in the treatment of chemotherapy-induced anaemia

Published on 2015/04/21

A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology and oncology has shown the biosimilars to be effective and well tolerated ...

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Right of appeal provision in CETA

Published on 2015/04/17

The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1], with certain prov...

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WHO proposal offers clarity for biosimilar nomenclature

Published on 2015/04/15

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized nam...

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Biosimilar trastuzumab similar to Herceptin in non-clinical study

Published on 2015/04/13

Comparative non-clinical assessments of the proposed trastuzumab biosimilar PF-05280014 and the originator product (Herceptin) sourced in the US and in Europe showed similar structural properties, t...

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Use of biosimilars in Europe differs across countries

Published on 2015/04/09

In Europe, the use of biosimilars exhibits different rates in different countries. This can lead to inequalities in access to biologicals, for instance, for the treatment of autoimmune diseases such...

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Switching and extrapolation of subsequent entry biologics in Canada

Published on 2015/04/07

The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed in the country. Biosimilars, which are known as subsequent entry biologi...

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EC expected to dish out more pay-for-delay fines

Published on 2015/04/03

The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations ...

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Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity

Published on 2015/04/01

Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar pharmacokinetic properties compared to the originator products [1, 2]. ...

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Data protection provisions in CETA

Published on 2015/03/30

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provis...

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Court rules Canadian drug regulators cannot control generics’ prices

Published on 2015/03/26

Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics. The country’s Federal Court ruled in cases brought against t...

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Biosimilar infliximab comparable to Remicade

Published on 2015/03/24

Results from a phase III trial have demonstrated the comparability of US-based Epirus Biopharmaceuticals (Epirus) biosimilar (BOW015) to Remicade for the treatment of rheumatoid arthritis. Th...

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EMA changes transparency plans to increase access to data

Published on 2015/03/20

The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the EMA interface were criticized for limiting acces...

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