Biosimilar insulins: a European perspective
نویسندگان
چکیده
Biosimilar insulins are likely to enter clinical practice in Europe in the near future. It is important that clinicians are familiar with and understand the concept of biosimilarity and how a biosimilar drug may differ from its reference product. The present article provides an overview of biosimilars, the European regulatory requirements for biosimilars and safety issues. It also summarizes the current biosimilars approved in Europe and the key clinical issues associated with the use of biosimilar insulins.
منابع مشابه
Current and Future Perspectives on the Development of Biosimilar Insulins for Diabetes Management
• The European Medical Agency (EMA) has issued regulatory guidelines for the development of biosimilar insulins that emphasize pharmacokinetic/pharmacodynamic studies rather than efficacy evaluations. In the United States, biosimilar insulins are currently covered by the Food and Drug Administration’s (FDA) 505(b)(2) pathway permitting evaluation of the reference product. Current and Future Per...
متن کاملBiosimilar insulins: guidance for data interpretation by clinicians and users
Biosimilar insulins are approved copies of insulins outside patent protection. Advantages may include greater market competition and potential cost reduction, but clinicians and users lack a clear perspective on 'biosimilarity' for insulins. The manufacturing processes for biosimilar insulins are manufacturer-specific and, although these are reviewed by regulators there are few public data avai...
متن کاملThe Future of Biosimilar Insulins
IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, ...
متن کاملAn Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins
Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars we...
متن کاملIntroduction of biosimilar insulins in Europe
Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar® ), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered ...
متن کامل