The Peruvian president has issued decrees regulating biologic originators and biosimilars, with the Ministry of Health forecasting 30–60% reductions in biologic medicine prices due to the new regulations.
IHS Life Sciences perspective | |
Implications | With support from the minister of health, the Peruvian president has published the decrees 011-2016-SA and 013-2016-SA regulating biologic originators and biosimilars, respectively. |
Outlook | The regulations will facilitate the market entry of biosimilars and are likely to reduce biologic medicine prices by between 30% and 60% compared with that of the originator. The decrees will be implemented within 180 days and establish specific regulations for biosimilars already in the market. |
With the support of the minister of health, the Peruvian president has issued decrees 011-2016-SA and 013-2016-SA regulating biologic originators and biosimilars, respectively. The former decree was published yesterday (2 March) after the government received criticism for leaving out specific regulations for biosimilars (see Peru: 2 March 2016: Peruvian government approves biologic originators regulation but postpones approval of biosimilars regulation). Decrees 011-2016-SA and 013-2016-SA can be accessed here and here, in Spanish.
Decree 013-2016-SA outlines requirements for the registration of biosimilar products through the comparative route. The requirements closely follow the international standards set by the World Health Organization, and establish a case-by-case approach to determine the need of pre-clinical and clinical testing conducted by the Peruvian department for medications and drugs (Digemid).
According to the Ministry of Health, the regulations will facilitate the market entry of biosimilars and are likely to reduce biologic medicine prices by between 30% and 60% compared with that of the originator. The regulations are the result of an arduous legal procedure started in 2012. Several drafts were presented by the MoH and discussed through public consultation with the participation of the international and national pharmaceutical industry, civil society, healthcare professional associations, and patients.
Outlook and implications
The introduction of these two decrees that distinguish clearly between biologic originators and biosimilars was more than expected in Peru and the positive results that the market could achieve are evident in terms of reduced biologic medicine prices and increased competition in the market. This is especially so considering that a potential approval of the Trans-Pacific Partnership (TPP) is likely to extend biologic originator patents and may increase their prices (see Peru: 9 October 2015: Peruvian government secures 10-year transition period to incorporate TPP).
However, facilitating biosimilars entry in the Peruvian market would negatively affect the innovative pharmaceutical firms in Peru that have been well positioned in a market with few biosimilars.
The decrees will be implemented within a period of 180 days and they establish specific regulation for the biosimilars already in the market that do not fulfil the new requirements. The Peruvian health authority had previously allowed the sale of some medicines that were claimed to be biosimilars, but without any demonstrable safety, quality, and comparability of the products with their biologic originators (see Peru: 1 April 2015: Peru's government to regulate biosimilars in July).
Despite the fact that a proper biosimilars regulation has recently been recommended as a relevant measure to be implemented across the Latin-American region by the Pan-American Health Organization (PAHO) and the Generics and Biosimilars Initiative Journal (GaBI Journal), the regulation of the biosimilars industry has been difficult even in some developed markets, such as Spain. Despite clear challenges, there has been progress in some countries in Latin America, such Brazil, Colombia, and Mexico, which currently have regulations that facilitate the registration of biosimilars. However, some regional countries, such as Uruguay, are still in the process of incorporating biosimilars regulations.