Onkológia 5/2018
Biosimilars versus a brand name drugs
Original medicines, including biologics, contain original molecules that have been approved by a national or central European Medicines Agency (EMA) procedures. In the registration dossier of the original medicinal product, therefore also of the biological medicinal product, the manufacturer has to submits all required information on the clinical safety and efficacy of the molecule. Since the authorization dossier is approved, the original drug become unique on the market and the manufacturer is protected for a number of years from the possibility of generic medicines or, in the case of a biosimilar medicinal products, a similar biological product. Unlike a generic drug that must contain the same moleucule, in the same dosage form with the same dosage and application route, the biosimilar drug, due to its molecular character and the biotechnological manufacturing process, has to be only similar to referral biological medicine. Therefore, a biosimilar / biosimilar drug is only approved as a similar drug, but with exactly declared equivalent efficacy and safety for the patient. Today, EMA has more than a decade of biosimilar experiences that has been gaining since its first approval in 2006. Based on these, at prčesent time the biosimilars are fully accepted in clinical practice in biology therapy and guarantee effective and safe treatment for our patients. In EU, biological and biosimilar medicines are only approved through a centralized procedure, and there is full support for the introduction of biosimilar medicines by all EU countries. This is mainly due to the prevention of the overshoot risk of biological medicinal products, due to the very technical and time-consuming biotechnological production process, and the possibility of significant pressure to lower the price of these medicines. The healthcare system thus creates scope for more efficient spending with public resources that can be invested in other healthcare areas and bring higher benefits. It will ensure the subsequent broadening for the better approach to innovative biological therapy. However, it should not be forgotten that biological treatment, whether original or biosimilar, has its innovative character and cutting edge scientific understanding. It many open questions and problems that will be gradually answered on the basis of the pharmacovigilance of individual drugs as well as progress in molecular medicine.
Keywords: brand-name drug, generic drug, biological medicine, biosimilar
