Steven R Feldman1. 1. Department of Dermatology, Wake Forest University School of Medicine, 4618 Country Club Road, Winston-Salem, North Carolina 27104. Electronic address: sfeldman@wakehealth.edu.
Abstract
OBJECTIVES: To discuss considerations regarding the selection, prescribing, and monitoring of biosimilars in the clinical management of patients with inflammatory disorders. METHODS: A search of the Internet as well as PubMed was conducted through August 2014 for information related to the clinical use of biosimilars in chronic inflammatory disorders using the keywords biosimilar, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn׳s disease, ulcerative colitis, and ankylosing spondylitis. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites were searched for biosimilar guidelines. RESULTS: Articles and guidelines relating to integrating biosimilars into the clinical management of patients with inflammatory disorders have been published by regulatory agencies, professional associations, healthcare providers, and others. CONCLUSIONS: The recent approval of the biosimilar infliximab in some countries makes biosimilars a reality for rheumatologists and others involved in the care of patients with inflammatory disorders. To successfully and confidently integrate biosimilars into clinical practice, physicians must understand factors such as variation in innovator/reference products, extrapolation of data, naming and labeling, interchangeability and automatic substitution, and pharmacovigilance.
OBJECTIVES: To discuss considerations regarding the selection, prescribing, and monitoring of biosimilars in the clinical management of patients with inflammatory disorders. METHODS: A search of the Internet as well as PubMed was conducted through August 2014 for information related to the clinical use of biosimilars in chronic inflammatory disorders using the keywords biosimilar, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn׳s disease, ulcerative colitis, and ankylosing spondylitis. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites were searched for biosimilar guidelines. RESULTS: Articles and guidelines relating to integrating biosimilars into the clinical management of patients with inflammatory disorders have been published by regulatory agencies, professional associations, healthcare providers, and others. CONCLUSIONS: The recent approval of the biosimilar infliximab in some countries makes biosimilars a reality for rheumatologists and others involved in the care of patients with inflammatory disorders. To successfully and confidently integrate biosimilars into clinical practice, physicians must understand factors such as variation in innovator/reference products, extrapolation of data, naming and labeling, interchangeability and automatic substitution, and pharmacovigilance.