title: Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology.
abstract: Biologics are vital to the management of patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions. Nevertheless, access to these highly effective treatments remains an unmet medical need for many people around the world. As patents expire for existing licensed biologic (originator) products, biosimilar products can be approved by regulatory authorities and enter clinical use. Biosimilars are highly similar copies of originator biologics approved through defined and stringent regulatory processes after having undergone rigorous analytical, non-clinical, and clinical evaluations. The introduction of high-quality, safe, and effective biosimilars has the potential to expand access to these important medicines. Biosimilars are proven to be similar to the originator biologic in terms of safety and efficacy and to have no clinically meaningful differences. In contrast, "intended copies" are copies of originator biologics that have not undergone rigorous comparative evaluations according to the World Health Organization recommendations, but are being commercialized in some countries. There is a lack of information about the efficacy and safety of intended copies compared with the originator. Furthermore, they may have clinically significant differences in formulation, dosages, efficacy, or safety. In this review, we explore the differences between biosimilars and intended copies and describe key concepts related to biosimilars. Familiarity with these topics may facilitate decision making about the appropriate use of biosimilars for patients with rheumatic and musculoskeletal diseases.
authors.affiliation: Reumatólogo en Organización Médica de Investigación, Buenos Aires, Argentina.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Mysler
authors.affiliation: Instituto Nacional de Rehabilitacion, Mexico City, Mexico.
authors.forename: Carlos
authors.initials: C
authors.lastname: Pineda
authors.affiliation: Kyushu University Beppu Hospital, Beppu, Japan.
authors.forename: Takahiko
authors.initials: T
authors.lastname: Horiuchi
authors.affiliation: Pfizer Inc., Collegeville, PA, USA.
authors.forename: Ena
authors.initials: E
authors.lastname: Singh
authors.affiliation: Pfizer Inc., Collegeville, PA, USA.
authors.forename: Ehab
authors.initials: E
authors.lastname: Mahgoub
authors.affiliation: Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA.
authors.forename: Javier
authors.initials: J
authors.lastname: Coindreau
authors.affiliation: Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA. ira.jacobs@pfizer.com.
authors.forename: Ira
authors.initials: I
authors.lastname: Jacobs
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012219:Rheumatology; D013810:Therapeutic Equivalency
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals
keywords: Biologic; Biosimilar; Intended copy; Pharmacovigilance; Regulatory