title: Position Paper from the Portuguese Association of Hospital Pharmacists for biosimilar therapeutic antibodies.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Goncalves
authors.affiliation: Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.|Faculdade de Ciências da Saúde, Universidade da Beira Interior, Covilhã, Portugal.
authors.forename: P
authors.initials: P
authors.lastname: Matos de Brito
authors.affiliation: CHVNG, Espinho, Portugal.
authors.forename: A
authors.initials: A
authors.lastname: Batista
authors.affiliation: CHUC, Hospitais da Universidade de Coimbra, Coimbra, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Feio
authors.affiliation: CHUC, Hospitais da Universidade de Coimbra, Coimbra, Portugal.
authors.forename: F
authors.initials: F
authors.lastname: Machado
authors.affiliation: ULS, Guarda, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Aperta
authors.affiliation: Hospital Beatriz Angelo, Loures, Portugal.
authors.forename: I
authors.initials: I
authors.lastname: Ascensão
authors.affiliation: IPO, Lisboa, Portugal.
authors.forename: V
authors.initials: V
authors.lastname: Pires
authors.affiliation: Hospital Vila Franca de Xira, Vila Franca de Xira, Portugal.
authors.forename: C
authors.initials: C
authors.lastname: Oliveira
authors.affiliation: CH Póvoa de Varzim, Vila do Conde, Portugal.
authors.forename: R
authors.initials: R
authors.lastname: Armandina Pontes
authors.affiliation: Hospital Garcia de Orta, Almada, Portugal.
authors.forename: A
authors.initials: A
authors.lastname: Alcobia
authors.affiliation: CHLC - Hospital Santa Maria, Lisboa, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Paulo Cruz
authors.affiliation: ULSBA, Beja, Portugal.
authors.forename: S
authors.initials: S
authors.lastname: Lampreia Guerreiro
authors.affiliation: Hospital Egas Moniz, Lisboa, Portugal.
authors.forename: H
authors.initials: H
authors.lastname: Farinha
authors.affiliation: CUF-Descobertas, Lisboa, Portugal.
authors.forename: A
authors.initials: A
authors.lastname: Margarida Freitas
authors.affiliation: CHUC, Hospitais da Universidade de Coimbra, Coimbra, Portugal.
authors.forename: M
authors.initials: M
authors.lastname: Caetano
authors.affiliation: Hospital Garcia de Orta, Almada, Portugal.
authors.forename: P
authors.initials: P
authors.lastname: Almeida
authors.affiliation: IPO, Lisboa, Portugal.
authors.forename: B
authors.initials: B
authors.lastname: Costa
authors.affiliation: IPO, Lisboa, Portugal.
authors.forename: C
authors.initials: C
authors.lastname: Oliveira
authors.affiliation: Hospital Pedro Hispano, Sra. da Hora, Portugal.
authors.forename: C
authors.initials: C
authors.lastname: Campos
authors.affiliation: Hospital São Francisco Xavier, Lisboa, Portugal.
authors.forename: B
authors.initials: B
authors.lastname: Madureira
authors.affiliation: Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.
authors.forename: M
authors.initials: M
authors.lastname: Cavaco
authors.affiliation: British Hospital Lisbon XXI, Lisboa, Portugal.
authors.forename: H
authors.initials: H
authors.lastname: Catarino
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D010595:Pharmacists; D010607:Pharmacy Service, Hospital
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals
keywords: ankylosing spondylitis; automatic substitution; biosimilar; extrapolation; infliximab; interchangeability; position paper; review; rheumatoid arthritis; switching