Special aspects of biosimilars as an object of intellectual property
Abstract
Main factors of the development of biosimilars market are their high efficiency, the availability of evidential base, a reasonable price compared to the original products, broad field of application, the social importance and increasing interest in these states and pharmaceutical companies for their production.
The aim of the work is analysis of special aspects and main trends in development of patenting of technical solutions for the creation of biosimilars and their pharmacoeconomic evaluation.
It has established that biosimilars meet the criteria of patentability are requiremented for inventions: novelty, inventive step, industrial applicability. The main objects of biosimilar patent are pharmaceutical composition, methods of producing the API, new dosage form, the methods of treatment, a new indication for known drugs, and others. Objects of the invention at biosimilar patenting are: increase in the yield of the desired product; simplification of method; reducing the time of the method; increasing purity of the target product; expanding resource base; increase stability, increase or enhancement of pharmacological activity, increased bioavailability, decreased toxicity of the desired product, improved consumer properties and others. It was characterized the strategy of legal protection of biosimilars by foreign applicants, including in Ukraine, Russian Federation, the European Union and United States. It was showed significant pharmacoeconomic benefits of biosimilars by domestic production (cost below 2.5 times) compared to the original drug.
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