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News

Celgene settles Revlimid patent litigation with Natco Pharma posted 09/02/2016

Celgene Corporation (Celgene) is to provide India-based Natco Pharma and its US partner, Arrow International – a unit of Alle...

Australian approval for infertility biosimilar Bemfola posted 09/02/2016

Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regul...

Filgrastim follow-on biological approved in Brazil posted 01/02/2016

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), annou...

Bevacizumab non-originator biological approved in Russia posted 22/01/2016

Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the compa...

EMA accepts application for etanercept biosimilar posted 15/01/2016

Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etane...

 

Research

Positive phase III results for cetuximab and infliximab copy biologicals posted 05/02/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 11 January 2016 that its partner, MabTech ha...

Lack of health insurance limits access to biologicals in India posted 05/02/2016

One example of a negative driver of the ‘similar biologics’ market in India is the lack of health insurance in the country [1].

Prescribing similar biotherapeutic products in Latin America posted 29/01/2016

Prescribing practices vary across different countries in Latin America and reveal gaps in understanding and in the use of dis...

Partnerships driving similar biologics development in India posted 29/01/2016

With biosimilars grabbing an increasing share of the global biologicals market and with India providing a cheaper place to ca...

Doctors in the US should remember to prescribe generics posted 28/01/2016

According to the findings of a literature review carried out by the American College of Physicians (ACP) the major obstacle t...

 

General

Biosimilar etanercept offered at 47% discount in Norway posted 05/02/2016

Samsung Bioepsis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar et...

Biosimilars approved in Australia posted 05/02/2016

Last update: 5 February 2016In Australia, the legal framework for approving medicines was established via the Therapeuti...

‘Similar biologics’ approved and marketed in India posted 05/02/2016

Last update: 5 February 2016There have been established guidelines for approving generic versions of small molecule chem...

Biosimilars approved in Europe posted 05/02/2016

Last update: 5 February 2016In the European Union (EU), a legal framework for approving biosimilars was established in 2003....

Biosimilars applications under review by EMA – December 2015 posted 05/02/2016

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...