Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America

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.

PANLAR consensus statement on biosimilars

“…In the USA, the FDA has specified that biosimilars should have unique nonproprietary names that are distinguished from those of their reference products by four-letter suffices which are devoid of meaning [27]. In Mexico, Colombia, Argentina, Brazil, and Chile, there is no nonproprietary naming convention to distinguish biosimilars from their reference products [28]. The World Health Organization recommends that the standard international nonproprietary name (INN) system be used for biosimilars to enable easy recognition of the active ingredient [29].…”

“…Studies have estimated that the potential savings in the USA from using biosimilars over a 10-year period could range between USD $25 billion and USD $100 billion [36]. In Chile, Brazil, and Mexico, biosimilars are priced 20 to 35% lower than their reference biologics in [28]. Mestre-Ferrandiz and colleagues suggested that, as physicians become more confident about the data supporting interchangeability between biosimilars and their reference products, the prices could decrease, provided that incentives are in place for both payers and patients to benefit from price competition [37].…”

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…46,48 The term “biosimilar” is not necessarily used in each case; in Mexico, for example, “biocomparables” is the official term. 49 Other countries, such as Bolivia and Paraguay, are in the process of developing or finalizing legislation. 46–48 In general, the region is moving toward increasing standards of regulation, and the WHO guidelines have been adopted or used as a basis for guidance in several instances.…”

“…For example, in addition to a “complete dossier” pathway and a comparative pathway similar to the respective approval routes for novel biologics and biosimilars in other countries, regulations in Colombia describe a third, “abbreviated” comparative pathway via which a biologic can be evaluated. 46,49,51 The abbreviated pathway has attracted substantial criticism that it deviates markedly from international norms and does not provide certainty that a product approved by this route would have an acceptable benefit–risk profile, 46,49,52,53 although such claims have been refuted by authors in Colombia. 54,55 In another example, although Brazilian biologic approval guidelines from the Agência Nacional de Vigilância Sanitária (ANVISA) describe a comparative pathway for the approval of biosimilars akin to that in the WHO guidance, there is a lack of clarity regarding the nature of the clinical studies that are needed.…”

“…46,49 In the US, an interchangeable biosimilar is defined as one that, in addition to meeting criteria for biosimilarity, will also provide “the same clinical result as the reference product in any given patient” and “for a product administered to a patient more than once, there is no additional risk or reduced efficacy if a patient switches back and forth between an interchangeable product and a reference product, compared to using the reference product without switching.” 152 Interchangeable designation by the FDA may permit pharmacy-level substitution of a biosimilar for the corresponding originator product without the intervention of the prescriber, although substitution policies are to be determined according to state-level legislation. None of the biosimilars licensed to date in the US are designated as interchangeable because the FDA has yet to finalize the standards by which it will assess interchangeability.…”