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EU publishes consensus report on biosimilars Posted 03/05/2013

The European Commission’s (EC’s) Enterprise and Industry Directorate-General has published a new report providing comprehensive information on the concept of biosimilars.

The consensus information document ‘What you need to know about Biosimilar Medicinal Products’ was approved by the EC Steering Group on Access to Medicines in Europe on 17 April 2013 and was presented at the BIO International Convention in Chicago, USA, on 23rd April 2013.

The document details Europe’s strong regulatory and commercial foundation for biosimilars in the healthcare marketplace and shows that biosimilars are helping improve competition and thus may be increasing access to biologicals for patients. The report is designed to help national governments, healthcare professionals and patients make informed choices on the role current and future biosimilars may have in achieving optimal healthcare outcomes.

Some key findings and messages of the document include:

  • Biosimilars enhance competition in the European Union (EU), potentially improving patient access to biologicals by offering a cheaper alternative to expensive brand-name biologicals.
  • Biosimilars have been available in the EU since 2009, providing additional therapeutic options for physicians and patients; however, their uptake varies widely between different countries.
  • All classes of biosimilars are experiencing annual double-digit sales growth without automatic substitution, demonstrating the power of effective competition.
  • Patients must be fully involved in the decision to take any biological medicine following thorough discussion with their prescribing doctor of all the treatment options.
  • Patients should speak to their physician and pharmacist when switching from one biological medicine to another.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), its specialized group the European Biopharmaceutical Enterprises (EBE) and the European Association for Bioindustries (EuropaBio), along with biotech giant Amgen all welcomed the documents findings.

Amgen, who was involved in the consultation process for the report, recently announced plans to commence a pivotal study for a biosimilar of Roche’s blockbuster breast cancer drug Herceptin (trastuzumab) in the second quarter of 2013.

The European Generic medicines Association (EGA) said that ‘continued education of all stakeholders is needed’ and that EU Member States need to ‘take action to boost market access for biosimilars’, which EGA believes could be done by rolling out the consensus information document on biosimilars.

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EU guidelines for biosimilars

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Source: Amgen, EFPIA, EGA, Europa

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