Rapid uptake of rheumatoid arthritis biosimilars expected in Brazil and Mexico

Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients with rheumatoid arthritis (RA) in Brazil and Mexico, which both have powerful mechanisms that drive use of lower cost options.

According to a new report from health care advisory firm Decision Resources, public formularies, treatment guidelines, public tender acquisition processes and prescriptions all reference only the molecular name of drugs in this sector in Brazil and Mexico, allowing for automatic integration of biosimilars with the same molecular name as currently covered branded biologics. Public tender, in particular, forces acquisition of the lowest-priced version of a drug, regardless of rheumatologist preferences.

The special report, titled The Biosimilar Opportunity in Brazil and Mexico: How to Succeed and Thrive - Payer and Rheumatologist Perspectives, finds that the current government in Brazil is investing in the national production of biosimilars to reduce the significant cost of imported, branded biologics for RA.

Opportunities for partnerships

“Viable opportunities for productive development partnerships (PDPs) to produce biosimilars in Brazil still exist and confer many benefits in the public sector market,” said Decision Resources director Andreia Ribeiro, adding: “In fact, competing with PDP biosimilars in the public sector will be difficult upon their availability.”

In addition, Brazil offers two approval pathways for non-original biologics: the individual development pathway and the comparability pathway. Approval via the comparability pathway for a PDP biosimilar will likely allow for exportation to other countries. Several PDPs that are developing biosimilars for RA have already determined that they will file through this pathway.

Three RA biosimilars already available in Mexico

Biosimilars are not yet available in Brazil. In Mexico, three copy biologics are already prescribed in public institutions for RA, according to interviewed payers and surveyed rheumatologists.

Most surveyed rheumatologists in both countries prefer branded biologics, and they can influence their continued use in the private sector. Physician preference for branded drugs will likely continue in the private setting, where private HMOs (health maintenance organizations) make direct purchases from manufacturers. Once biosimilars are available, the prices of the original brands of biologics are expected to drop to compete, and private insurance will likely be the only means for patients to access original brands, says the report.