The example of the two-pathway system coupled with governmental prioritization of local manufacturing capabilities in Brazil should promote increased biosimilar utilization within the country. Assuming that the two-pathway system demonstrates success in Brazil, we hypothesize that other Latin American countries may adapt aspects of this "local" model for developing a regulatory pathway for biosimilars.

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and effi cacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature reviews, followed by exploratory qualitative interviews (N = 10) with payers and physician key opinion leaders (KOLs) selected based on input from regional industry experts (payers) and PubMed search (KOLs). Interviews were 60 minutes, using a structured set of questions, in local language. Results: Respondents place the budget impact of the originator product and clinicians' acceptability as the most relevant drivers for the adoption of biosimilars. Payers and KOLs alike expect biosimilars to demonstrate non-inferiority versus originator in phase 3 RCTs (randomized clinical trials) to support bioequivalence, safety and effi cacy claims. Payers' comfort in providing access to biosimilars across disease areas and expectations for cost savings vary by markets, according to previous experience with other biosimilars and confi dence in the regulatory evaluation. As a result, payer discount requirements for public access range from 5-30% across markets, with KOLs stating that they likely will consider biosimilars for all patients at discount levels greater than 20−25%. Conclusion: Although payers and physicians alike cited the importance of bioequivalent safety and effi cacy, they ultimately will look to regulators for guidance on which biosimilar products have provided suffi cient evidence, and for which indications. While the level of discount versus the branded originator varied by market, biosimilars have the potential to gain broad penetration with cost-sensitive public payers and also with clinically-oriented physicians across Latin American markets. Study objectives As with generic small-molecule medicines, the potential for cost savings resulting from the use of biosimilars is attractive to payers worldwide [1, 2]. This attraction has increased sharply in recent years as the impact of biological drugs on health plan budgets has exploded. In Brazil, for example, biotherapeutic products represented 2% of medicines prescribed, yet accounted for 41% of the annual Ministry of Health pharmaceutical budget in 2010 [3]. Biosimilars, however, are different than small molecule generics due to the inherent variability in the production process for biopharmaceutical products and the relatively limited experience that stakeholders have with them. Physicians in particular raise concerns about the degree to which this variability in production may result in differing levels of safety and effi cacy of biosimilars relative to their branded equivalents-and each other. Fear of potential immunogenicity issues arising from differences in the biological production process is a concern with biosimilars, and is associated with...

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A667 ate the efficacy and safety of new anticoagulants in the treatment of AF. Methods: Health Technology Assessment of multiple technologies. We searched the electronic databases Cochrane Library, CRD, Pubmed, Embase and Lilacs, to search for the best available evidence assessing the new oral anticoagulants, compared with warfarin in patients with AF. Results: Three randomized controlled trials evaluating dabigatran (110mg e 150mg), rivaroxaban 20mg and apixaban 5mg were included, all of them compared with warfarin. In this regard, dabigatran 110mg was associated with similar rates of stroke or systemic embolism and with a 20% relative risk reduction (RRR) of major hemorrhage compared with warfarin. Dabigatran 150mg was associated with a 34% RRR of stroke or systemic embolism and similar rates of major hemorrhage. Rivaroxaban 20mg was associated with similar rates of the primary efficacy and safety outcomes. Finally, apixaban was associated with a 21% RRR of stroke or systemic embolism and with 31% RRR of major bleeding compared with warfarin. ConClusions: There is strong evidence supporting these new technologies, especially regarding safety. Further studies are needed to support decision making, especially with regards to cost-effectiveness issues.

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