News


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...

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...

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...

Biosimilar policies in Spain

Published on 2013/01/21

Spain is Europe’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 Products...

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...

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 ...

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...

The latest biosimilars agreements

Published on 2013/01/11

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

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...

EMA approves first generic imatinib

Published on 2013/01/07

EMA’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 pote...

Glossary of key terms

Published on 2013/01/01

Last update: 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 p...

MSF launches online ‘Patent Opposition Database’

Published on 2012/12/27

The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing cou...