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Momenta gains approval to start biosimilar adalimumab trial in Europe posted 12/12/2014

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medi...

Stada to in-license adalimumab biosimilar posted 11/12/2014

German generics giant Stada Arzneimittel (Stada) announced on 18 November 2014 that it was in negotiations to in-licensing an...

Biosimilar infliximab launched in Japan posted 11/12/2014

Japanese pharma firm Nippon Kayaku announced on 28 November 2014 the launch of its infliximab biosimilar, Infliximab BS, in J...

Amgen expands biosimilars programme posted 11/12/2014

Biologicals major Amgen is expanding its biosimilars portfolio to include nine different molecules.

Amgen launches biosimilars info app posted 11/12/2014

Biologicals major Amgen has launched an app which aims to provide a source of information about biosimilars.

 

Research

Extrapolation of indications in biosimilars: epoetin posted 15/12/2014

Despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low, and especially...

Non-biological complex drug concept: experiences with iron sucrose and low molecular weight heparin posted 15/12/2014

When the patent of a classical small molecule drug expires, generics may be marketed if their therapeutic equivalence to the...

US biosimilar uptake in the light of Obamacare posted 12/12/2014

A literature review by researchers at Tufts University in the US concludes that market uptake of biosimilars in the US will d...

Use of biosimilars in rheumatology posted 12/12/2014

In order to issue a position statement on the use of biosimilars in rheumatic diseases, the Sociedade Portuguesa de Reumatolo...

Comparison of biosimilar filgrastim versus other G-CSF formulations after autologous stem cell transplantation posted 12/12/2014

IntroductionOnly limited data have been so far published about the use of biosimilar filgrastim in haematologic recovery aft...

 

General

Biosimilars approved in Japan posted 05/12/2014

Last update: 5 December 2014In Japan, the regulatory body for the approval of medicines, including biologicals, is the M...

Subsequent entry biologics approved in Canada posted 05/12/2014

Last update: 5 December 2014 In Canada, the regulatory body for the approval of medicines is the Therapeutic Products Di...

EuropaBio calls for distinguishable names for biosimilars despite potential of big savings posted 28/11/2014

On 6 November 2014, the European Association for Bioindustries (EuropaBio) published a new guide and a new position paper on...

More discussion over WHO biological qualifier posted 21/11/2014

The World Health Organization recently held its 59th Consultation on International Nonproprietary Names (INN) for Pharmaceuti...

Biosimilars approved in South Korea posted 21/11/2014

Last update: 21 November 2014In South Korea, the regulatory body for the approval of medicines, including biologicals and bio...

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