engleski

Biosimilar drugs and the similarity concept

Biosimilar is a medicine that is similar to the originator biologic therapy and approved after data protection has expired for original biological medicine. Biosimilars are not completely identical to original biological medicine but because they are proteins or peptides they have the same amino acid sequence and highly similar glycosylation patterns. These biologic therapies (original and biosimilar biologics) have been produced using recombinant DNA technology in living systems and extracted through complex purification techniques. Like in the case of “classical” generics (small-molecule drugs) their main advantage is related to financial savings and this is of special interest because of high and increasing costs for biological therapy for the health care system worldwide. The regulatory agencies (European Medicines Agency, Food and Drug Administration) have established regulatory framework (nonclinical and clinical guidelines) for assessing biosimilars that is different from the process required for generics. Some of the challenges in the biosimilars assessment are in the fact that efficacy and toxicity are difficult to predict because of the possibility that subtle molecular changes could have profound effects on clinical efficacy, safety and immunogenicity. This is the reason why regulatory agencies require, before approval, non-inferiority or equivalence trials (efficacy and safety, and immunogenicity) as well as post-marketing pharmacoviligance and identification of the product. Extrapolation of indication for biosimilars or acceptance of data from clinical trials in a given condition to other diseases by regulatory agencies is also debatable question. In clinical practice, when treating patients with biosimilars, the most important issue is connected with interchangeability, automatic substitution and switching. In conclusion, biosimilars usage will provide financial savings and greater patients’ accessibility to biological therapies, but it is of utmost importance to increase the knowledge of patients and physicians concerning this group of medicines.

Biosimilar ; Regulatory agencies ; Extrapolation ; Immunogenicity

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