The pharmaceutical market is enjoying double-digit growth in Latin America, and the rheumatoid arthritis (RA) market in Brazil and Mexico is characterized by a growing prevalent population with greater access to medical care and by rheumatologists’ increasing use of more aggressive treatments. The value of biologics in the treatment of RA is recognized by medical authorities (including both regulatory and health technology assessment bodies) in these markets as they try to keep pace with access to biologics in mature markets. Biologics from several drug classes are therefore available in these markets for RA, and most of them are covered/reimbursed by healthcare providers in each country. However, the high-cost of RA treatment with biologics imposes a significant financial burden on the public healthcare systems in Brazil and Mexico, where the most patients rely entirely on government-sponsored healthcare to receive treatment. The economic impact of treating the growing RA population with biologics is increasing the cost pressures on healthcare authorities thus creating an attractive opportunity for biosimilar manufacturers to explore. For the design of a successful market access strategy, understanding the factors that will drive and restrict biosimilar performance in key Latin American markets is crucial. The following are some key factors:
- Non-innovative biologic copies for the treatment of RA are already available in Mexico, but only branded biologics are available in Brazil.
- In Brazil, several biosimilars for the treatment of RA are under development by Productive Development Partnerships (PDPs): strategic partnerships comprising government-funded laboratories, local manufacturers, and multinational corporations.
- Several biosimilars are expected to launch in the next three years: biosimilars of Amgen/Pfizer’s Enbrel [etanercept], Janssen/Merck’s Remicade [infliximab], Roche’s MabThera [rituximab], AbbVie’s Humira [adalimumab], and UCB/Astella’s Cimzia [certolizumab pegol].
- Both Brazil and Mexico have dedicated regulatory pathways for biosimilars.
- The public sectors of Brazil and Mexico are dominated by the public tender acquisition process and are strongly price-driven. In the private sector of both countries, however, branded drugs are typically preferred.
Our report explores the competitive space for biosimilar development in Brazil and Mexico, regulatory and reimbursement pathways for these agents, and strategies for maximizing the biosimilar opportunity in these rapidly evolving markets.
Questions Answered in This Report:
Understand the future impact of biosimilars for RA under development:
What is the status of the biosimilars market in Brazil and Mexico? Which local and foreign companies are targeting immunobiologics brands and conducting clinical trials in Brazil and Mexico? What is the development status of emerging biosimilars? Which strategic partnerships have been forged for the development of biosimilars in these markets? How do immunobiologics rank among the drug classes being targeted by these partnerships?
Understand the regulatory process for biosimilars:
What are the regulatory pathways and requirements for biosimilars in Brazil and Mexico? How do approval guidelines differ between each market and compare with EMA guidelines?
Understand patient access and reimbursement for biosimilars for RA:
What are the barriers to biosimilar access at the prescriber level in the public and private (Brazil only) sectors? How will payer policies in Brazil and Mexico impact uptake of biosimilars over currently approved biologics? What clinical and commercial factors would be most likely to convince payers to grant emerging biosimilars formulary coverage or advantaged positioning?
Understand which attributes of biosimilars are value drivers among rheumatologists and payers:
How do rheumatologists and payers in Brazil and Mexico perceive biosimilars developed by multinational corporations versus domestic manufacturers? How will these perceptions impact prescribing? What are the rheumatologists’ and payers’ expectations for formulary inclusion or formulary coverage extension to biosimilar versions of RA biologics? What are rheumatologists’ and payers’ opinions concerning interchangeability and automatic substitution as well as indication extrapolation for biosimilars? What are clinician and payer attitudes toward the pricing of biosimilars?
Understand government initiatives to regulate and expand access to biosimilars:
How will access to biosimilars be controlled, or favored, in each market? Are government initiatives under way to expand access to biosimilars? What impact will the PDPs have on the entrance of foreign biosimilars to Brazil?
This Special Report—Market Access explores the dynamics that affect sales of biosimilars and branded biologics used to treat RA in Brazil and Mexico. The report is based on a survey of 104 rheumatologists and interviews with 7 payers and 4 rheumatologist key opinion leaders (KOLs). Interviewees were required to be influential in determining patient access to key biologics used in the treatment of RA at the institutional (KOLs) or regional/ national level (payers), including the current and future uptake of biosimilars (and other copy biologics), and include the following:
- Brazil: Health division director at the State Health Secretariat of São Paulo; Consultant ad-hoc at ANVISA, CONITEC, and the MoH; Pharmacist director at the Assistance Services of Pharmacy at Hospital de Clínicas, University of São Paulo (USP); Member of the committee for standardization of drugs and protocols of the Health Department of the State of São Paulo Pharmaceutical responsible for the pharmacy department of the Hospital das Clínicas de São Paulo, USP; Rheumatologist KOL, member of the Brazilian Society of Rheumatology and Paulista Society of Rheumatology; Rheumatologist KOL, member of the Brazilian Society of Rheumatology, CFM, and AMB.
- Mexico: Subdirector of regulations and hospital attention at ISSSTE; Director of affiliated health care rights/chief of reimbursement at IMSS; Chief of internal audit for medication at the Secretaria de Salud (Health Secretariat - MoH); Rheumatologist KOL from the Mexican College of Rheumatology and Pan American Associations for Rheumatology; Rheumatologist KOL from the Mexican College of Rheumatology and Mexican Council of Rheumatology.