Below we leave you the ten fundamental guidelines to understand what biosimilar medicines are. This is a summarized version of the Decalogue that you can find on the website of biosim:
- biosimilar
A biosimilar (or similar biological medicine) is a biological medicine that contains essentially the same active substance as a reference original biological product, to which it has been shown to be equivalent in quality, efficacy and safety. The biosimilar is authorized for all or some of the indications approved for the reference product, and its dosage and route of administration are the same as those of the reference product.
- Biological drug/biotechnological drug
A biosimilar drug is a biological drug (or biodrug); that is to say, a medicine that contains an active principle of biological origin. As such, it is produced in a living organism by means of a procedure equivalent to that of any biological, and with the same quality criteria. Their biological nature, and as a consequence, their structural and functional complexity, distinguishes them from medicines obtained through chemical synthesis procedures (or "small molecules").
- comparability exercise
The comparability exercise refers to the studies necessary to verify the equivalence between biological drugs; whether these batches are of the same biological medicine, or a candidate for biosimilarity with respect to its original reference product. In the development of a biosimilar, extensive and rigorous comparative experimental studies are required in parallel between the biosimilar candidate and the reference drug.
- EMA guarantee
The team of experts from the European Medicines Agency (EMA) that evaluates the dossiers of original biological medicines also does so with biosimilar candidates, and applies the same criteria regarding the degree of demand in the benefit/risk balance estimated as acceptable.
- Extrapolation
The EMA and the other reference regulatory agencies, on occasions, and in accordance with strict scientific criteria, extend the safety and efficacy data to a disease, or to a population of patients, different from the one studied, or studied, during development. clinical. This principle, called extrapolation, has been applied to original biologics. It is also applicable to biosimilar medicines with an equivalent guarantee.
- therapeutic exchange
Prescribing physicians sometimes change a biological treatment in a given patient for another analogue, for clinical or other reasons. This practice, called swapping, is frequently applied between originator biologics with no particular ill effects reported. For this reason, it is estimated that the reciprocal exchange between two products that have passed a comparability exercise as exhaustive as the biosimilar and its corresponding original reference product should not be associated with a significant clinical risk.
- Substitution/ "No Substitution" Regulation
Substitution is understood as the dispensing by the pharmacist of a medication other than that prescribed by the doctor without prior consultation with the latter. In Spain, by law, in pharmacies (or street pharmacies), the substitution of a medicine of biological origin for another is not authorized, whether the biosimilar or the original has been prescribed. In hospitals, where the Pharmacy and Therapeutics Commissions are the decision-making body, it is essential that a consensus be reached with the doctors regarding the selection of biological medicines.
- immunogenicity
Immunogenicity is the quality of immunogenicity; that is, the propensity of a drug to induce an immune response against itself. Except in the case of vaccines, it is an undesirable phenomenon, attributed mainly to biological medicines. The EMA therefore requests laboratories that develop biological products, whether original or biosimilar, to carry out extensive immunogenicity studies during their development.
- Traceability and experience
The prescription by commercial name, and the registration of the same and of the batch in the pharmaceutical dispensing, are sufficient guarantee of the traceability of the biological product that is administered at all times to each patient. Spain, and in general any country covered by the EMA, has established a rigorous process of pharmacovigilance. This allows us to state that, since the first biosimilar was launched in 2006, no increase in notifications of adverse effects or clinical consequences associated with immunogenicity has been reported.
- Patient accessibility and sustainability
The incorporation of biosimilar medicines into healthcare systems allows a greater number of patients to benefit from biological treatments. In certain cases it has also facilitated the optimization of therapeutic protocols. By promoting competition in the pharmaceutical market, biosimilar medicines contribute to the economic sustainability of national health systems, and encourage research into new products. Both facts consolidate the guarantee of quality health coverage for future generations of patients.
Consult the complete decalogue here.