| dc.description.abstract | Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while
maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities
of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis
in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil,
Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars
in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars
in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and
standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and
Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the
similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy
makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability,
pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for
more Latin American countries to establish national psoriasis registries and to integrate their common components
into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin
American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical
companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to
identify potential regional trends or differences in safety or outcomes | |
