In Brazil, Government and Industry Partner to Develop Biosimilars

In 2010, Brazil’s National Health Surveillance Agency (ANVISA) established criteria for biosimilar approval, forming a comprehensive pathway for these products for the first time. The guidelines, Collegiate Board Resolution 55/2010, provides 2 ways in which a biosimilar can be approved: comparability and individual development.

The comparability demonstration is similar to that described by the World Health Organization. Under Brazil’s comparability pathway, biosimilars require comparative data from preclinical as well as phase 1 and phase 3 clinical studies in relation to the reference product, and the extrapolation of indications is permitted. Robust pharmacovigilance systems, similar to those in place for the reference drug, are required.

Read more about biosimilars in Brazil.

However, the individual development pathway differs significantly from the comparability pathway; individual development requires comparative data only from preclinical trials and phase 3 confirmatory studies, with no requirement to produce comparative data from phase 1 studies. Extrapolation of indications for products developed in this manner are not permitted, and these products may not be treated as interchangeable with their references.

For both types of biosimilar products, explains a newly published paper, Brazil benefits from a program known as the Partnership for Productive Development (PPD), which brings together government and the private sector to develop strategic products of interest to the Brazilian health system—including biosimilars of the high-cost biologics that account for approximately half of annual drug spending.

In an arrangement that the paper calls a “win-win opportunity” for both government and private companies, under a PPD agreement, the master cell bank for a biologic is required by law to be transferred to the government organization participating in the agreement for use in manufacturing, and the biosimilar maker develops a product that will then be purchased directly by the Brazilian Ministry of Health. Thus, the government establishes a supply of a cost-reducing product, and the biosimilar developer ensures robust sales of its product. Biosimilars that are currently part of such agreements include rituximab, adalimumab, and bevacizumab.

The impact of such agreements on Brazil’s healthcare system has the potential to be significant. At the same time, nationalizing production of biosimilars presents an opportunity, say the paper's authors, for the nation to positive impact its trade balance, generate tax revenue, and provide jobs in Brazil.

Reference

Scheinberg MA, Felix PAO, Kos IA, Andrade MA, Azevedo VF. Partnership for productive development of biosimilar products: perspective of access to biological products in the Brazilian market. Einstein (Sao Paulo). 2018;16(3): eRW4175. doi: 10.1590/S1679-45082018RW4175.