Regulatory Focus™ > News Articles > Similar Drugs in Brazil to Have Same Status as Generics

Similar Drugs in Brazil to Have Same Status as Generics

Posted 16 January 2014 | By Louise Zornoza

Brazilian Health Minister Alexandre Padilha and Dirceu Barbano, director of Brazilian regulatory authority Anvisa, have announced a public consultation on new rules that will grant "similar medicines" the same status as generics.

The move will allow pharmacists to provide consumers with a similar drug as a substitute to the branded product. This option, called interchangeability, is currently allowed only for generics.

The difference between similars and generics is that the former possess a trade or brand name, while the latter have only the generic name of the active ingredient. Brazil currently has 185 manufacturers of similar products, representing some 43% of the market, while generics and branded products respectively account for 27% and 21% of market share.

The change in a product's classification will be preceded by a price review by the Chamber for Drug Market Regulation (Cmed). Generic drugs currently cannot cost more than 65% of the cost of the reference product. Currently, adjustment of the price of similar products is made according to a formula established by Cmed, and the review does not necessarily lead to a linear reduction in their price. 

With the new scheme, the Ministry of Health hopes to reduce the price of similar drugs, which, like generics, will be required to be priced 35% lower than the reference products.

The change in policy also reflects a 2003 decision by Anvisa setting the end of this year as a deadline for similar medicines to submit bioequivalent testing for agency approval, a requirement that has always existed for generics.  Following approval, similar drugs will be called "equivalent" medications and their packaging will bear a yellow band with the "EQ" symbol, like generic medicines. "The symbol will help consumers and doctors to know that the product has proof of equivalence and have the exactly same therapeutic function as reference drugs," explained the director of Anvisa.

The expectation of the Ministry of Health is that by the end of 2014, all similar drugs will be technically equal to the reference products. "We are extending the same quality standards that have been established for generics. From the end of 2014, no similar product without equivalence testing may be marketed in the country," said Health Minister Alexandre Padilha. According to data from Anvisa, virtually all manufacturers of similar products are already in compliance with the requirement.


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