ASSESSMENT OF QUALITY OF GENERICS IN CARDIOLOGY: REALITY AND POSSIBILITIES

• Main Author: V. V. Yakusevich
• Format: Article
• Language: English
• Published: Stolichnaya Izdatelskaya Kompaniya 2015-12-01
• Series: Racionalʹnaâ Farmakoterapiâ v Kardiologii
• Subjects: generics; original drugs; pharmaceutical; pharmacokinetic; pharmacotherapeutic equivalency
• Online Access: https://www.rpcardio.com/jour/article/view/337

Wide presence of original drugs’ copies, the so-called “generics”, on the pharmaceutical market is analyzed. The positive side of this expansion is connected with the lower price of generics, which makes it possible to decrease the costs of treatment. From the other side with the advent of big number of copies of the original drugs it becomes more difficult to assess the quality of each particular generic. Russian legislation in the field of registration allows selling in the country almost all drugs, which have at least minimal similarity to the original. The problem of pre-registration studies of bioequivalency of original and analogue drugs, therapeutical equivalency is widely observed. Concrete proposals of how to prevent the overflow of the Russian market with the generics with the unproved efficacy and safety are considered.