Italian Medicines Agency publishes concept paper on biosimilars

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The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 1 August 2012 the release of a concept paper on biosimilars.


The purpose of the concept paper on biosimilar drugs is to ensure and promote the use of biosimilars in Italy by providing health professionals and citizens authoritative, clear, transparent, objective and validated information. Subjects covered by the concept paper include:

  • Definition and criteria for the characterisation and naming of biological medicines and biosimilars
  • Regulatory requirements in force in the EU with respect to biosimilars
  • Safety of biosimilars
  • Extrapolation of therapeutic indications for biosimilars
  • Role of biosimilars in the Italian healthcare system
  • Biosimilars as an alternative to brand-name products: the question of substitution

AIFA sees biosimilars as essential for the development of a competitive market and for the sustainability of the healthcare system. At the same time AIFA sees the importance of maintaining guarantees of safety and quality for patients and the role that biosimilars have in providing patients with timely access to medicines, even in the context of public spending cuts.

Biological medicinal products and biosimilars play a vital role in the treatment of many diseases, for this reason, AIFA considers it essential to provide a document whose purpose is to define the conditions in the pharmaceutical field to ensure proper use and access for biosimilar products.

The contents of the concept paper do not yet reflect the official position of AIFA in the field of biosimilars, but constitute a preliminary position on which to explore the different viewpoints of stakeholders through a public consultation.

The concept paper is available on the AIFA website for public consultation, by consumers, pharmaceutical companies, scientific societies, and others until 31 October 2012. A form for comments is available from

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Source: AIFA

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