Clinical Studies for Generic Drugs

Today local clinical studies of generics for marketing authorization purposes are highly demanded in Russia. ARS conducts annually tens of bioequivalence (BE) studies for its Clients at the specially equipped and qualified Phase I Units and collaborates with the leading PK laboratories in the country and abroad.

According to the current legislation, to apply for a generic drug registration to the Ministry of Health in Russia, a developer should submit results from own BE or TE (therapeutic equivalence) clinical study performed at the Russian sites. In a BE study, a reference product must be one for the first time launched to the Russian market and quality, efficacy, and safety of which were proven by preclinical and clinical research conducted in accordance with FZ-61. Drugs (not biologics), which are more than 20 years in medical use in Russia and not subject to BE research, are not to be investigated in TE study as well.

BE (= PK equivalence) studies in healthy volunteers are performed for drugs with extravascular administration (used orally - tablets, capsules, etc.; through rectal introduction; skin application). For parenteral and aerosol therapies, if no reference product in the Russian market, TE studies in patients are conducted. Furthermore, trials in healthy volunteers are not allowed for some psychotropic, anticancer, and HIV drugs regardless of a drug formulation and route of introduction. BE studies are executed for pharmaceuticals with immediate and retard release and combination drugs (FDCs). For drugs with different dosages a BE trial on a maximum dosage is performed.

Since 2016, a six-year marketing exclusivity has been set in Russia; herewith a reference drug has four years and a reference biologic - three years of data exclusivity.

Since 2016, if you fulfill the terms of article 18, it is not obligatory for generics in the form of aqueous solutions for parenteral / topical / oral application / sprays, and others to provide own data from TE studies in patients for marketing authorization purposes in Russia. In addition, there is no need any more to submit local clinical data to register orphan drugs in the country.

Ratification of the Treaty on common principles and rules of circulation of medicines in the Eurasian Economic Union (EEU) by the Russian Federation in January 2016  provides additional opportunities for optimizing generics’ registration strategies in the region, for instance, bio-waivers based on biopharmaceutics classification system, others.

As per analogues of biologics, the Russian authorities tend to follow the European standards; the scope of clinical research in Russia for registration purposes depends on a certain product and is different for biosimilars and biobetters. 

ARS team does its best to provide all kinds of high-quality support to its Clients bringing their generic products to the Russian market, including local clinical studies’ organization and conduct. ARS is ready to help with study documents design, regulatory support, site and PK lab selection, project management, clinical monitoring, logistics, study report preparation, others.