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Reproduced drugs must be interchangeable with respect to the reference drugs

Timofey Nizhegorodtsev, Head of the Department for Control of Social Sphere and Trade, presented the position of the regulator on drug interchangeability, speaking at the 25th Russian Pharmaceutical Forum in St. Petersburg on May 15.

“We are struggling with unscrupulous practices that emerged in the 1990s and greatly influenced the regulatory system of drug registration,”  Timofey Nizhegorodtsev began his speech.

The representative of the FAS reminded those presented the principles of drug registration in Russia, which are enshrined in the legislation. According to them, the reference drug is equivalent to that reproduced and vice versa.

“Thus, if a drug is registered as reproduced, it has already proved its equivalence — comparability, similarity — to a reference drug, which means their interchangeability. On the contrary, if equivalence to the reference drug is not proven, it cannot be registered as reproduced, ” said Timofey Nizhegorodtsev.

The speaker said that despite the differences in dosage forms, reproduced drugs proved their equivalence with reference drugs in the registration process. However, despite the established order of registration of drugs in Russia, there are additional (other) types of “reproduced” drugs. For example, registered in comparison with non-reference drug in the presence of a reference, or have indications for use and contraindications, methods of administration and use, etc. that differ from reference drug etc.

According to FAS Russia, “reproduced” drug, registered in comparison with non-reference drug in the presence of reference drug “de jure” cannot be considered to be reproduced, and “de facto” confirmed its “reproducibility” in clinical practice. In this regard, the antimonopoly authority proposes to introduce a transitional period in order for manufacturers to provide the missing information confirming the equivalence of such drugs to the corresponding reference drug.

If the “reproduced” drug has other indications for use and contraindications that differ from the reference drug, then, in the opinion of the FAS Russia, all the parameters of the drug reproduced should be brought in line with the reference medicine. An exception is the presence of its own clinical studies that cause these changes.

“Now we are talking about the fact that we need to clarify the legislation, which will eliminate the problems that arise in the framework of the work of the Ministry of Health of Russia on the interchangeability of drugs. Reproduced drugs should be interchangeable with respect to the reference. And, in principle, there are no problems to establish this within the registration dossiers, ”commented the head of the Department of Social and Trade Control.

Timofey Nizhegorodtsev spoke about the need to align the requirements for the quality of the registration dossier for all the drugs on the market, regardless of the requirements that were in force at any time during the registration of the drug. The measure is necessary because the lack of the same set of expertise and research in the registration dossier discriminates some manufacturers with respect to others. In addition, it creates conditions for unfair competition in the form of rumors about the ineffectiveness of generics, as well as confirmation of the equal quality of all generic and reference drugs sold on the market.

To eliminate problems with the establishment of interchangeability and the full launch of drug reimbursement programs, it is necessary to oblige drug manufacturers to conduct bioequivalence or therapeutic equivalence studies (with the exception of special formulations); establish a requirement to bring indications for use and contraindications in accordance with the instructions of the reference drug (except for the presence of its own research); provide for an adequate transition period; establish the characteristics of the treatment of such drugs suspend the appeal, and subsequently cancel the state registration in case of failure to bring the registration dossier and application instructions in line with modern regulatory requirements.

“We hope that the work will go faster. If before that we spent 10 years trying to identify a problem, describe it, discuss it, now the process has accelerated due to digitalization. In accordance with the instructions of the President of the Russian Federation and the Government of the Russian Federation, work related to the standardization, synthesis and description of drugs should be completed in a reasonable time, but as soon as possible. In this regard, those bills, and those decisions that are being prepared in this part, will be implemented in a priority order. We expect that by 2021 this work will be completed, ”concluded Timofey Nizhegorodtsev.

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