The term biosimilar indicates a medicinal product similar to a biological reference (originator) drug, already authorized in the European Union, for which patent coverage has expired. The concept of "similar biological medicinal product" was introduced into the legislation of the European Union by Directive 2001 / 83 / EC and subsequent amendments, while Directive 2004/27 / EC provided a definition of biosimilar product implemented in Italian legislation with Legislative Decree no.219 / 2006.
In 2012, the European Medicines Agency (EMA, from the English European Medicine Agency) released various documents concerning biosimilar drugs in which it is reiterated that a biosimilar medicine means a medicine developed in such a way as to be similar to a medicine. biological which has already been authorized and which is referred to as a 'reference medicine'.
Biosimilar medicines differ from generic medicines which have simpler chemical structures and which are considered equivalent to the medicines they originate from (read the Hoax). The active substance of a biosimilar and that of its reference medicine are, in fact, the same biological substance, although there may be minor differences due to their complex nature and manufacturing techniques.
A biosimilar and its reference product, therefore, being obtained by different methods, are not identical, but essentially similar in terms of quality, safety and efficacy. There is the possibility that, in some cases, the biosimilar drug may be derived from more innovative production processes than those of the reference drug, such as to ensure that the biosimilar product has even better quality profiles, for example in terms of impurities. Moreover, like the reference medicine, the biosimilar exhibits a certain degree of natural variability. From these assumptions it follows that a critical role in the evaluation process of a biosimilar is represented by the comparison of its quality profile with respect to that of the originator, by carrying out a “head to head” analysis. This examination precedes the comparative evaluation of safety and efficacy since only the satisfaction of the three aspects in their entirety will allow the biosimilar drug to be authorized.
In the European Union, all applications for marketing authorization (AIC) of biological medicines, including those for biosimilars, are examined by the EMA through a type of procedure at the end of which the authorization for placing on the market it is valid in all member states of the European Union. It is necessary that the reference product to which the application for marketing authorization of a biosimilar product refers, is a medicine already authorized in the European Union by the EMA or outside the European economic area by a regulatory authority that operates with scientific and regulatory standards equal to those of the EMA (Guideline on similar biological medicinal products CHMP / 437/04 Rev 1).
The Italian Medicines Agency (AIFA) clarifies in a position paper that, as regards the registration process, in Italy, in consideration of the fact that the biosimilarity assessment process is conducted, by the EMA and by the national regulatory authorities, at the highest level of scientific knowledge and on the basis of all available evidence, no further comparative assessments carried out at regional or local level are necessary.
The AIFA also clarifies that biological and biosimilar medicines cannot be considered as generic or equivalent medicines, thus excluding their reciprocal automatic therapeutic substitutability. AIFA considers biosimilars as interchangeable products with the corresponding reference originators since the relationship The risk-benefit of biosimilars is the same as that of the reference originators. This consideration applies both to naïve patients (who have never been treated) and to patients already being treated. The choice to prescribe a treatment with a biological drug of reference or with a biosimilar always remains a decision entrusted to the specialist doctor who is also entrusted with the task of contributing to an appropriate use of resources for the purposes of sustainability of the health system and the correct information of the patient on the use of biosimilars.
The applicability of the general principles to the individual products and / or to the individual therapeutic categories described in the position paper, may be reconsidered by AIFA based on the time to market of the medicines, the number of patients treated in clinical practice, the scientific evidence, as well as of the data acquired over time.
This position, which is also shared by other European regulatory authorities, is being continuously updated on the basis of scientific elements that have emerged over time. To be emphasized in this sense, what is expressed in the guideline Biosimilars in the EU - Information guide for healthcare professionals precisely in support of behaviors to be adopted at the level of the individual country.Bibliography
Legislative Decree 24 April 2006, n. 219. Implementation of directive 2001/83 / EC (and subsequent amending directives) relating to a community code concerning medicinal products for human use, as well as directive 2003/94 / EC (GU General Series n.142 of 21-06-2006 - Ordinary Supplement no. 153)In-depth link
European Medicines Agency (EMA). Biosimilar Medicines
European Medicines Agency (EMA). Biosimilars in the EU. Information guide for healthcare professionals
Italian Medicines Agency (AIFA). According to AIFA Position Paper on biosimilar drugs