Brussels, 19 April 2013 The European Federation of Pharmaceutical Industries & Associations (EFPIA), its specialised group the European Biopharmaceutical Enterprises (EBE) and the European Association for Bioindustries (EuropaBio) welcome the consensus information document on biosimilars that was approved by the European Commission Steering Group on Access to Medicines in Europe on 17^th April. The Commission will present the document at the BIO international Convention in Chicago on 23^rd April. The document discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure there is informed and adequate use of these medicines.

 Some key highlights of the document findings include:

• Biosimilars enhance existing market competition in the European Union (EU) and may offer a less-costly alternative to existing biological medicinal products which have lost their exclusivity rights.
• Biosimilars are available in every EU member state, providing additional therapeutic options for physicians and patients.
• 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.

“We welcome this document which shows that biosimilars are not generic medicines, but a different and valued version of biological medicines which lose their market exclusivity. It is important to recognise how they are giving physicians and patients an additional treatment option while allowing payers to better manage healthcare expenses and enabling access to a larger number of patients” explains Richard Bergström, EFPIA’s Director General. “This consensus information document highlights the importance of understanding the value of all biological medicines, including biosimilars, to help improve patient care and outcomes.”

"EuropaBio supports the document’s findings and will continue educating the public on the opportunities and challenges associated with biotechnology, including biologic and biosimilar medicines. The development and manufacturing process for all biologic medicines, including biosimilars, is more complex compared to the processes associated with generics and other chemical, small molecule products,” commented EuropaBio Secretary General Nathalie Moll.  “This is why it is important to maintain a robust regulatory and risk management framework, enhance label transparency and continue education on biosimilars and all biological medicines, to ensure that patients and physicians fully understand either type of therapy.”

The document’s findings were formally approved by consensus from key stakeholders across Europe, including; European Commission, health reimbursement authorities from EU member states, patient, physician and payer representatives as well as  industry representatives drawn from the key European trade bodies including EFPIA and EuropaBio.

The document shows that the price differentials between biosimilar medicinal products and their reference medicinal products have not been as substantial as expected and that the most important conditions for market uptake of biosimilars lie within the commercial marketplace in each country and not in forced utilisation measures such as automatic substitution, which is not authorised in any EU member state. “Applying the generics approach to biological medicines would not be sensible because biological medicines, including biosimilars, are structurally more complex, thus making them similar, not identical. Furthermore automatic substitution of biologics or biosimilars would make post marketing surveillance more complicated, and determining potential lack of efficacy or suspected adverse events to specific molecules would be extremely difficult", said Roberto Gradnik, President of EBE.