Comprehensive EFPIA principles launched 30^th September 2015, are designed to create and secure a sustainable and competitive off-patent biologic medicines market that balances efficient patient access to the most appropriate medicine for an individual patient and effective cost management across Europe.

With an increasing number of biologic medicines set to lose patent protection in the coming years, the EFPIA policy principles have been devised to encourage competition, while establishing essential headroom for governments and payers to further invest in innovation.

The principles also take into account the unique characteristics of biologic medicines, reinforcing the need to ensure specific policies for biologic products, rather than transferring them wholesale from the generics sector.

EFPIA stresses that three key characteristics are specific to European biologic markets and should be taken into consideration when forming policies relating to biologic medicines.

• In contrast to small molecule generics, interchangeability and/or substitution cannot be assumed between originator biologic medicines and biosimilars.
• Product level traceability of biologic medicines is vital and enhances routine pharmacovigilance – a vital tool in the safeguarding of patient health.
• Biosimilars cost $100-200 million to develop and take 8-10 years to produce, compared with generics, which cost $1-5 million to develop and take 3-5 years to produce. A smaller number of entrants and higher market prices for biosimilars will mean the level of price erosion seen in small molecule-based medicines would not be realistic or sustainable in competitive off-patent biologic medicines markets.

EFPIA’s approach to off-patent market for biologic medicines is based on the following principles:

• Patients should have access to the best treatment that reflects their individual needs;
• All biologics, originators and biosimilars approved by the European Medicines Agency (EMA) are safe, effective and of high quality;
• Biologic medicines are not the same as small molecules and policies must therefore be designed specifically for biologic medicines;
• The option to designate which biologic medicine should be dispensed to a patient must always fall to the prescribing physician;
• To support adverse event reporting, robust pharmacovigilance systems must be in place, including the requirement for prescribing of product brand name and reporting of product brand name and batch number for all biologic medicines;
• Competition in off-patent pharmaceutical/biologic medicines markets is essential in order to generate savings, contribute to the sustainability of health systems and foster innovation. 

The EFPIA principles also introduce proposals for creating sustainable competition, establishing a prescribing framework and addressing specific market mechanisms, including purchasing and procurement practices and uptake measures.

EFPIA firmly believes that by applying these rigorous, non-discriminatory principles, European healthcare systems will succeed in balancing patient access to medicine and cost management in the off-patent biologic medicines sector.