On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same topic.

Relevance of AIFA Position Paper

The number and importance of biological medicinal products purchased by the National Health System (NHS) is constantly increasing. So it is their cost, in particular, for hospitals, which are often their ultimate purchasers. While in Italy territorial expenditure (i.e. for products distributed by territorial pharmacies to patients) seems to be under control, hospital expenditure is of concern, not least for the impact of highly innovative and expensive medicinal products made available by the Industry in the last years, while more are expected to come.

As patent protection on biological medicinal products expires, substitution of biological medicinal products with biosimilars may become a compelling need for hospitals to meet budgetary constraints. However, as physicians and experts know (and it is stipulated by EMA’s Guidelines), biosimilars are not identical to the original biological products of reference.

AIFA Position Paper 2013

This is acknowledged by AIFA’s Position Paper of 2013, which clearly states that biosimilars cannot be regarded as equivalent products and therefore no room is left for their automatic substitution by pharmacies. While “the choice to use a biological medicinal product or a biosimilar should be made by the physician prescribing the therapy“, AIFA noted that “biosimilars not only are a therapeutic option available to the treating physicians, but they should be preferred, if they are of economic advantage, in particular for the treatment of naive patients“. In sum, biosimilars are not identical and are not interchangeable with the reference biological medicinal products (in the meaning of an automatic substitution in the therapy). For patients under treatment the use of biosimilars should be decided by the physician, provided that no safety and efficacy risks may derive to the patient.

AIFA Second Concept Paper

No material changes are proposed by AIFA as to the general principles. However, the agency seems to want to open the door for a more frequent use of biosimilars also for non-naive patients. The Second Concept Paper now proposes that the “biosimilar is a therapeutic option whereby the risk-benefit ratio is the same as for the corresponding original biological product of reference, as it is proved by the regulatory assessment procedure for the authorisation. Such considerations apply also to the patients under treatment, where the opportunity of the change is left to the clinical appreciation of the physician“.

That said, as biologicals and biosimilars are not identical (and this is still the opinion of AIFA), the risk-benefit ratio may be comparable but it is not necessarily the same. Moreover, the essential difference between biological and biosimilar products may still justify a different approach for naive patients and for those under treatment.

Since AIFA’s Second Concept Paper is intended for the discussion with the relevant stakeholders, we do not rule out that such aspects may be subject of additional considerations also on accounts of input from the Industry and the medical profession.

Comments on the Second Concept Paper are due by September 15, 2016.