Position Paper from the Portuguese Association of Hospital Pharmacists for biosimilar therapeutic antibodies. (11th November 2016)

• Record Type: Journal Article
• Authors: Goncalves, J.; Matos de Brito, P.; Batista, A.; Feio, J.; Machado, F.; Aperta, J.; Ascensão, I.; Pires, V.; Oliveira, C.; Armandina Pontes, R.; Alcobia, A.; Paulo Cruz, J.; Lampreia Guerreiro, S.; Farinha, H.; Margarida Freitas, A.; Caetano, M.; Almeida, P.; Costa, B.; Oliveira, C.; Campos, C.; Madureira, B.; Cavaco, M.; Catarino, H.
• Other Names: Marques Ana Rita Lopes investigator.; Arriegas Carla investigator.; Garcia Daniela Goulart investigator.; Aires Deolinda investigator.; Chaves Isabel investigator.; Costa José Ferreira da investigator.; Gomes Adriano Castro investigator.; Roque Ana Paula investigator.; Vieira Dina Maria investigator.; Pires Fernanda investigator.; Magalhães Luisa investigator.; Coelho Maria Cristina investigator.; Batista Vera investigator.; Filipe Ana Rute investigator.; Rosete Isabel investigator.; Sebastião Isabel investigator.; Gomes Luís Manuel investigator.; Rocha Patrocinia investigator.; Neta Susana Maria Oliveira e investigator.; Vaz Célia Sofia investigator.; Ribeiro Maria Raquel investigator.; Marques Nuno investigator.; Melo Olinda investigator.; Jorgensen Sónia Fonseca investigator.; Faria Luís Filipe investigator.; Monteiro Maria Adelaide investigator.; Mesquita Tânia investigator.; Ribeiro Carla investigator.; Paixão Carla investigator.; Mesquita Rui investigator.
• Is Part Of: Journal of clinical pharmacy and therapeutics. Volume 42:Number 2(2017)
• Page Start: 239
• Page End: 243
• Publication Date: 2016-11-11
• Subjects: ankylosing spondylitis -- automatic substitution -- biosimilar -- extrapolation -- infliximab -- interchangeability -- position paper -- review -- rheumatoid arthritis -- switching; Clinical pharmacology -- Periodicals; Chemotherapy -- Periodicals; 615
• DOI: 10.1111/jcpt.12477
• Languages: English
• ISSNs: 0269-4727

Abstract

Summary: What is known and Objective: Biopharmaceuticals are an important class of drugs for the treatment of autoimmune/inflammatory and oncologic diseases. With patent expiries, biotechnological manufacturers can now develop biosimilar drugs. Due to timeliness of introducing new and more complex biosimilars, the Portuguese Association of Hospital Pharmacists gathered to develop a common positioning on the use of biosimilar monoclonal antibodies. Main issues: The European pathway to biosimilar approval was developed to improve affordability and access to biological therapies, but it remains a work in progress because unresolved issues remain. Due to the present reality of biosimilar monoclonal antibodies, hospital pharmacists must play an important role in ensuring the safe, effective and cost‐effective use of biosimilars in health systems; and educating healthcare administrators, providers, legislators, policymakers, payors and patients about these products. What is new and conclusion: The conclusions presented in this work focused on the proposal for optimal biosimilar prescription criteria, the preparation of original biologics and biosimilars in the pharmacy, the management and selection of suppliers, extrapolation issues, the specific role of pharmacovigilance and risk management for the optimal use of biosimilar monoclonal antibodies. Abstract : This work focused on the proposal of optimal biosimilar prescription criteria, the preparation of original biologics and biosimilars in the pharmacy, the management and selection of suppliers, the specific role of pharmacovigilance and risk management for the optimal use of biosimilar monoclonal antibodies.