Current Medical Research and Opinion (10/15) Declerck, P.; Mellstedt, H.; Danese, S.

In a new report, European researchers aim to clarify the terms used with biosimilars. In addition, they seek to address what they call "an important knowledge gap which is currently resulting in an increasing rush to position biosimilars for certain indications and patients in the absence of agreed upon definitions." With the patents for a number of leading biologic drugs expiring soon, there has been an increase in the development of biosimilar or follow-on drugs. But the researchers note that the complex issues surrounding the molecular structures and manufacturing processes involved with biosimilars have led to some confusion with regard to terms such as regulatory approval, pharmacovigilance, interchangeability, and treatment-naivety. The lack of clarity, they say, "makes quantitative evaluation of biosimilars a great challenge to both the scientific community and regulatory agencies."

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