New Psoriasis Study Findings Recently Were Reported by C. de la Cruz and Co-Researchers (Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America)
By a News Reporter-Staff News Editor at Health & Medicine Week New research on Skin Diseases and Conditions - Psoriasis is the subject of a report. According to news originating from Santiago, Chile, by NewsRx correspondents, research stated, "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."
Our news journalists obtained a quote from the research, "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."
According to the news editors, the research concluded: "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."
For more information on this research see: Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America. The Journal of Dermatology, 2016;44(1):3-12. The Journal of Dermatology can be contacted at: Blackwell Publishing Inc, 350 Main St, Malden, MA 02148, USA (see also Skin Diseases and Conditions - Psoriasis).
The news correspondents report that additional information may be obtained from C. de la Cruz, Clinica Dermacross, Santiago, Chile. Additional authors for this research include A.V. de Carvalho, G.L. Dorantes, A.M. Londono Garcia, C. Gonzalez, M. Maskin, N. Podoswa, J.S. Redfern, F. Valenzuela, J. van der Walt and R. Romiti.
The publisher's contact information for the The Journal of Dermatology is: Blackwell Publishing Inc, 350 Main St, Malden, MA 02148, USA.
Keywords for this news article include: Chile, Santiago, Marketing, Psoriasis, Advertising, Dermatology, South America, Article Review, Papulosquamous Skin Diseases and Conditions.
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