Brazil Approves First Generic Version Of Sovaldi
Executive Summary
Brazil’s first generic version of Sovaldi for hepatitis C is approved.
ANVISA, Brazil’s medicines regulator, has approved the country’s first generic version of Gilead’s hepatitis drug Sovaldi (sofosbuvir).
The registration for the generic was awarded to the local firm Blanver Farmoquimica e Farmacêutica SA and was published in the official journal on May 21. Blanver was part of a product development partnership, or PDP, alongside Farmanguinhos, the state-owned Institute of Pharmaceutical Technology.
It was Farmanguinhos that last year filed a petition opposing a sofosbuvir patent application from Gilead. (Also see "Brazil Prepares To Make Its Own Sovaldi As Regulator Opposes Patent Application" - Pink Sheet, 7 Apr, 2017.) ANVISA then rejected the patent, as it is able to do in line with the contentious “prior consent” mechanism. This allows the regulator to object to a patent application on the grounds of public health, although INPI, the patent office, makes the final decision.
Another PDP for the development of sofosbuvir involves a technology transfer deal between Gilead, the Brazilian company Nortec and the state-owned laboratory Lafepe. "Gilead is a pioneer, working very fast in the development of hepatitis C drugs worldwide. The idea with the partner is to enable Lafepe to become a platform for production, perhaps even for the export of medicines,” said the commercial director of Lafepe, Djalma Dantas, when the lab announced the PDP in April.
PDPs are part of a program that dates back to 2008 and which aims to cut Brazil’s trade deficit in pharmaceuticals by encouraging the local production of treatments that are imported. The emphasis is on drugs that are of importance to the SUS, Brazil’s public health system.
Lower Costs
Anvisa believes that the newly approved generic will lead to savings on the drug as generics typically launch at a cost that is at least 35% lower than that of the reference product, it said in a statement. According to Lafepe, PDPs can bring the cost of a drug down by 70%.
The cost of Sovaldi has proved highly controversial in Brazil, as it has in many countries, despite protracted discussions and initiatives aimed at bringing the price down. These include the establishment of a Latin American joint procurement mechanism. (Also see "Latin American Countries Set Up Joint Procurement Mechanism" - Pink Sheet, 4 Jan, 2016.)
Brazil has a high burden of hepatitis C: around 1.6 million people live with the virus there.
From the editors of Scrip Regulatory Affairs.