Article 13 of the Law “On Circulation of Medicines” (the Law) in Russia provides a list of medicines that are subject to state registration (namely, the grant of marketing authorization (MA)) by the Ministry of Health (MoH)), namely:
- Medicines that have not (previously) been introduced into circulation in Russia;
- Previously approved medicines produced in other (e.g., new) medical forms (in accordance with a list of names of such medical forms (e.g., a new dosage form that justifies its clinical relevance and efficacy)); and
- New combinations of previously approved medicines.
The Law also specifically defines the terms “reference medicine”, “generic medicine” and “biosimilar medicine”. Thus, under 1) above, medicines that are subject to state registration include medicines having the following definitions:
Reference medicine: A medicine: (i) which has first been approved in Russia; (ii) whose quality, efficacy and safety have been confirmed by the results of pre-clinical and clinical trials; and (iii) which is used for assessment of bioequivalent or therapeutic equivalency, quality, efficacy and safety of a generic or biosimilar medicine;
Generic medicine: A medicine (i) which contains the identical composition (either in terms of quality or quantity) of active ingredients in the same dosage form as the reference medicine; and (ii) the bioequivalent or therapeutic equivalency of which has been confirmed by relevant studies; and
Biosimilar medicine: A biological medicine having similar quality, quantity and safety parameters as a reference biological medicine having the same dosage form and mode of administration.
The Law provides data exclusivity in Articles 18.20 and 18.21 and market exclusivity in Article 18.18. More specifically, these Articles recite:
Article 18.20: “Application for state registration of a generic medicine for medical use can be filed with an authorized federal executive body in charge of medicines state registration upon expiry of the four-year term from the date of the state registration of the reference medicine in the Russian Federation.”
Article 18.21: “Application on the state registration of biosimilar medicine can be filed with an authorized federal executive body in charge of medicines state registration upon expiry of the three-year term from the date of the state registration of the reference medicine in the Russian Federation.”
Article 18.18: “Use for commercial purposes of the information on the results of medicine preclinical and clinical studies provided by an applicant for registration of the medicine is not permitted without the applicant’s agreement during 6 years from the date of the medicine state registration of the reference medicine.”
As recited in the Articles 18.20 and 18.21, the data exclusivity period is four years from the date of marketing authorization of the reference medicine for small molecules and three years for large molecules (e.g., biologics). During the four (for small molecules) and three (for large molecule) data exclusivity period, the MoH will not accept a generic or biosimilar application. A reference medicine automatically receives data exclusivity as a result of it being the first MA approved by the MoH. As such, there is no requirement for registering for data exclusivity rights in Russia. In fact, based on our experience, data exclusivity for reference medicines appears to be working well in Russia.
Furthermore, Article 18.18 establishes an additional marketing exclusivity period of two years for small molecules and three years for large molecules thus providing for a total data and marketing exclusivity period of six years for both small and large molecules. However, because Article 18.18 is vague and somewhat confusing, there is nothing in this Article that prevents or prohibits the MoH from approving a generic or biosimilar application within the 2 or 3-year marketing exclusivity period. Therefore, a generic or biosimilar could launch a product at risk prior to the end of the 6-year data and marketing exclusivity period. If a generic or biosimilar did in fact launch before the end of the 6-year period, the reference product holder (e.g., innovator) would be able to sue the generic/biosimilar for launching before the end of the 6-year period. To date, this scenario has not yet occurred in Russia, but is a possibility.
Please continue to watch BRICS & Beyond for updates on data and marketing exclusivity in Russia.
This post was written by Lisa Mueller and Vladislav Ugryumov of Gowlings.