Substitutability of Hepatitis C drugs, established by FAS, saved more than 18 million RUB to the budget

FAS sent explanations to the Ministry of Health Care of the Russian Federation on preparing documents for procurement of medicinal drugs with the  “Cepeginterferon alpha-2b” and “Peginterferon alpha-2b” International Non-Proprietary Names (INN)

In 2016 FAS was approached by “Biocad” CJSC – a manufacturer of medicinal drugs with the “Cepeginterferon alpha -2b” INNwith a request to recognize substitution of medicinaldrugs with the “Cepeginterferon alpha-2b” and “Peginterferon alpha-2b” INN.

FAS analyzed the basic prescribing information, responses of theMinistry of Health Care and medical organizations and issued explanations that in spite of different INN, medicinaldrugs with “Peginterferon alpha-2b” INN in the pharmaceutical form – “lyophilisate for solution for subcutaneous administration” and medicinaldrugs with the “Cepeginterferon alpha-2b” in the pharmaceutical form – “solution for subcutaneous administration”, contain the same active substance – “pegylated interferon alpha-2b” and can be used to treat adult patients as part of Hepatitis C combined therapy.

Then FAS received a petition from “R-Pharm” CJSC, upon considering which FAS drafted additional explanations that, preparing documents for procurement of medicinal drugs with the “Cepeginterferon alpha-2b” INN to treat adult patients (Hepatitis C combined therapy), the ordering parties also must make sure that suppliers of equivalent medicinal drugs with “Peginterferon alpha-2b” INN can simultaneously participate in such procurement.

Guided by the position specified in the explanations, FAS investigated complaints of “R-Pharm” and “RUSMEDCOM” about actions of the Ministry of Health Care considering the bids for Nos. 0195100000217000142, 0195100000217000148, 0195100000217000147, 0195100000217000141 electronic auctions for supplies of a medicinal drug with “Cepeginterferon alpha-2b”. The Ministry rejected the bids that had offered to supply a drug with “Peginterferon alpha-2b” INN. FAS found the complaints justified and issued an injunction to the Ministry of Health Care to eliminate the violations.

Repeated procedure for procurement of a medicinal drug with “Peginterferon alpha-2b” INN under competitive conditions in view of FAS explanations reduced the initial (maximum) contract price from 44 to 60% (Nos. 0195100000217000142, 0195100000217000147, 0195100000217000141 procurements), which saved 18,825,840 RUB to the budget.

Deputy Head of FAS Department for Control over Social Sphere and Trade, Nadezhda Sharavskaya emphasized: “A repeated complaint from “Biocad” was especially strange since the company – a manufacturer of a medicinal drug with “Cepeginterferon alpha-2b”, that was given a possibility to take part in procurement of drugs with “Peginterferon alpha-2b” INN, asked to withdraw explanations on substitutability of the above medicinal drugs because according to “Biocad” CJSC these drugs are not substitutes”.  

To verify credibility of the arguments presented by “Biocad” CJSC FAS compared registration dossiers possessed by the Ministry of Health Care for all drugs under “Peginterferon alpha-2b” INN и “Cepeginterferon alpha-2b” and ascertained that the equivalency of these drugs is recognized by expert commissions.

Deputy Head of the specialized FAS Department stated: “Based on the inspection, despite “Biocad” petition, the Antimonopoly Service sent the explanations regarding its position to the Ministry of Health Care on preparing documentation for procurement of the above drugs”.