By Moeller IP Advisors
In Peru, patent coverage for branded pharmaceuticals lasts for 20 years from the date of filing, in line with most jurisdictions. Once the 20-year term has expired, the same product can be marketed as generic. A generic drug must be equivalent to a branded drug in dosage form, safety, strength, quality, and intended use.
As the development costs are lower, generics are generally cheaper than branded pharmaceuticals, while they ensure the same therapeutic effect. The World Health Organization recommends the implementation of Generic Drug Policies and in the last years, many Latin American countries have taken steps to increase access to more affordable pharmaceuticals.
According to data from the consulting company Pharmexcil, in 2016 the market of generics accounted for about the 38% of the total pharma market in Peru, totalling $ 605 million.
Regulation of generics pharmaceuticals in Peru
According to the recommendations issued by the WHO, generics must ensure that they achieve the very same therapeutic effect as a branded pharmaceutical. They should, before entering the market, undergo a bioequivalence test. Pharmaceutical equivalence entails that both generic and branded drug should have the same amount of the same active substance, in the same …Read More