FAS proved in court that the generic should be cheaper than the original

The Ninth Arbitration Court of Appeal has upheld the decision of the Federal Antimonopoly Service (FAS) to refuse approval of the maximum selling price for a reproduced (generic) drug, the antipsychotic Sulpiride, which was five times higher than the cost of the original drug.

"When conducting an economic analysis, the FAS Russia found that the cost of the reproduced drug Sulpiride was 4.7 times higher than the reference drug, Eglonil, in tablet form," the agency's website quotes the words of Nadezhda Sharavskaya, Head of the Office for Control of the Social Sphere and Trade.

As explained by the FAS, according to a law that came into force in 2015, reproduced (generic) drugs should not be more expensive than the original (reference) ones. Despite this, the manufacturer of Sulpiride, LLC "SVICH," did not apply a reducing coefficient.

The decision of the antimonopoly agency became the basis for refusing state registration of the maximum selling price for the drug Sulpiride.

The manufacturer attempted to challenge this decision in court but was unsuccessful.

It was previously reported that the FAS has begun the second stage of an international comparative analysis of prices for expensive drugs for the treatment of HIV and hepatitis in 39 countries. The agency completed the first stage of monitoring prices for drugs from the "Seven Nosologies" program list in September 2016. Only at the end of November, following corresponding recommendations from the antimonopoly service, did pharmaceutical companies begin voluntarily reducing prices for their drugs.