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EFPIA’s Principles Offer a Non-Discriminatory Solution to Enable Competition for Off-Patent Biologic Medicines

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Competition from biosimilar medicines provides a major opportunity for cost savings throughout Europe by making a significant contribution to the sustainability of National Healthcare Systems (NHSs) whilst improving patient access to innovative medicines in both the short and long term.

However, in order to deliver these benefits it is imperative that the off-patent biologic medicines market remains sustainable.

Creating sustainable competition between off-patent biologic medicines will be attractive and deliver continuing benefits to four key stakeholder groups (Physicians, Payers, Patients, and Industry) in both the short and long term. This competition, though, will only be effective if we have a level playing field, in which bias towards either originator or biosimilar medicines is not tolerated – a situation that would ultimately benefit society by balancing patient access to medicines, with effective cost management.

The solution comes in the form of a set of guiding principles that will help healthcare systems design and implement successful policies that are specific to off-patent biologic medicines.

In this respect, it is vital that the prescribing physician should always have the option to designate which biologic product should be dispensed to their patient so that the patient receives the best treatment to meet their individual needs.

It is important to stress that, from EFPIA’s point of view, biologic medicines and biosimilars are not two distinct elements of an “us” and “them” scenario. Our position is that all biologic medicines, originators and biosimilars approved by the European Medicines Agency (EMA) are safe, effective and of high quality.

Nevertheless, there are three key characteristics that are specific to European biologic medicines markets and should be taken into consideration when forming policies that relate to these products.

Unlike the small molecule generics market, interchangeability and/or substitution cannot be assumed between originator biologic medicines and biosimilars.

Product level traceability of biologic medicines is also a crucial element of this specific market sector, and would serve to enhance routine pharmacovigilance – a vital tool in the safeguarding of patient health. EFPIA is therefore pushing for measures to identify the product by brand name and batch number, both in policy and in practice, to ensure that a robust pharmacovigilance is in place.

Generic drugs are estimated to cost $1-5 million to develop and take 3-5 years to produce. By contrast, biosimilars will cost $100-200 million to develop and take 8-10 years to produce. What we are likely to see in the case of the latter is a market with a smaller number of entrants and higher market prices compared to markets for generics. Consequently the level of price erosion seen in small molecule-based medicines would not be realistic or sustainable with regard to competitive off-patent biologic medicines.

What we need, then, to ensure that a reasonable set of rules are put in place for the uptake of biosimilar medicines, that does not unnecessarily discriminate against originator biologic medicines. EFPIA contends that quotas and financial incentives/sanctions introduced by some countries have served only to restrict significantly the physician’s role in determining which patient gets which medicine. This may hinder patients from accessing the best treatment for their needs and fail to foster sustainable competition in an unbiased manner.

We would welcome a framework that explicitly retains doctors’ freedom to prescribe, through creating a level playing field between the off-patent originator biologic medicine and biosimilars. It will be vital to ensure that treatment decisions are always made in the first instance on the basis of clinical judgment and secondly on the basis of the overall value proposition offered by the individual medicine.

The EFPIA principles in their entirety offer an equitable opportunity to originator biologic medicines and biosimilars to play a fulfilling and meaningful role in enhancing patient health.

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