title: Impact of Biosimilar Insulins on Clinical Practice: Meeting Report.
abstract: The availability of biosimilar insulins can potentially lead to lower insulin costs and increased access for patients with diabetes, worldwide. However, clinicians and regulatory agencies have raised several concerns regarding the safety and efficacy of these new medications. The European regulatory agencies have established guidelines for market approval of biosimilar insulins; however, many issues remain unresolved. Moreover, although the FDA has developed preliminary pathways for biosimilar protein development and is prepared to review each application on a case-by-case basis, insulins do not fall under this pathway at this time. The development of effective postmarketing surveillance protocols, determination of product interchangeability, and product identification/labeling remain key concerns. Numerous issues surround the development and commercialization of biosimilar insulins; thus, it is important that all stakeholders fully understand the complexity of these issues and how they can potentially affect patient care. Bridging the educational gap among clinicians and regulatory agencies will be challenging but necessary for ensuring patient safety.
authors.affiliation: Arizona Endocrinology Center, Glendale, AZ, USA.
authors.forename: Richard O
authors.initials: RO
authors.lastname: Dolinar
authors.affiliation: University of San Diego, San Diego, CA, USA Taking Control of Your Diabetes, Del Mar, CA, USA svedelman@vapop.ucsd.edu.
authors.forename: Steve
authors.initials: S
authors.lastname: Edelman
authors.affiliation: Science & Company, Düsseldorf, Germany Profil Institute for Metabolic Research, Neuss, Germany Profil Institute for Clinical Research, San Diego, CA, USA.
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
authors.affiliation: Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Home
authors.affiliation: Sanofi US, Bridgewater, NJ, USA.
authors.forename: Shefali
authors.initials: S
authors.lastname: Goyal
authors.affiliation: University of California, San Diego, CA, USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Polonsky
authors.affiliation: Utrecht University, Utrecht, Netherlands.
authors.forename: Huub
authors.initials: H
authors.lastname: Schellekens
keywords: biosimilar insulin; immunogenicity; insulin; insulin analog; interchangeability