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Major shake-up of API import rules in Europe

Published on 2013/01/28

EU is seeking to impose good manufacturing practice (GMP) standards throughout the world in an attempt to stop the import of counterfeit or substandard active pharmaceutical ingredients (APIs) for hum...

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ABPI issues position paper on biosimilars

Published on 2013/01/25

The Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies in the UK, announced on 12 November 2012 the publication of its po...

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Pharmaceutical trade barriers are falling

Published on 2013/01/23

The European Parliament has voted in favour of a trade pact between Israel and the European Union (EU) that will allow easier access to medicines from both markets. The EU is also seeking to reduce ba...

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Biosimilar policies in Spain

Published on 2013/01/21

Spain is Europeâ€™s fifth largest pharmaceutical market, however, in 2009, biosimilars accounted for less than 5% of the total biologicals market. The Spanish Agency for Medicines and Health Pro...

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German court rules Seroquel XR patent invalid

Published on 2013/01/18

AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics. The pharma giant announced on 13 November 2012 that the Federal Pat...

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Dialogue needed to build confidence in biosimilars

Published on 2013/01/16

Concerns about the safety and efficacy of biosimilars have led many healthcare professionals to become reluctant to prescribe these products for their patients. According to a commentary by Dr Hans C ...

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Saving money in the European healthcare system with biosimilars

Published on 2013/01/14

Biotechnology-derived medicines are increasingly popular for treating a range of conditions from cancer to autoimmunity, and yet they are among the most expensive healthcare products owing to their ma...

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The latest biosimilars agreements

Published on 2013/01/11

Biosimilar is still the hottest subject around.Â Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpr...

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Overview of clinical research on generics in 2012

Published on 2013/01/09

Period: January to August 2012 Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain health...

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EMA approves first generic imatinib

Published on 2013/01/07

EMAâ€™s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib. Imatinib is a protein kinase inhibitor that...

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Glossary of key terms

Published on 2013/01/01

Last update:Â 13 February 2015 Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to...

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MSF launches online â€˜Patent Opposition Databaseâ€™

Published on 2012/12/27

The international medical humanitarian organisation Doctors Without Borders/MÃ©decins Sans FrontiÃ¨resÂ (MSF) has launched an online resource to help civil society and patient groups in developi...

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