The Future of Biosimilar Insulins

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...

Biosimilar insulins: a European perspective

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 th...

Biosimilar insulins: current and future perspectives

Introduction 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 ...

Biosimilar 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...