An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

Diabetes Technology & Therapeutics
L HeinemannPhilip Home

Abstract

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 were reviewed. Information was sourced through Internet searching and cross-referencing guidelines. As of August 2014, general biosimilar and insulin-specific guidelines are available in 34 countries and two countries/regulatory domains, respectively. Many guidelines are clearly related to, or partly derived from, the general and insulin-specific European Medicines Agency (EMA) guidelines. Areas covered by these guidelines are fairly consistent, covering preclinical, pharmacokinetic (PK), and pharmacodynamic (PD) studies in humans and clinical areas; however, there are differences in emphasis. The EMA insulin-specific guidelines include detailed criteria on PK/PD studies, as do most other general biosimilar guidelines and, to a lesser extent, clinical studies. The U.S. Food and Drug Administration has general biosimilar guidelines, emphasiz...Continue Reading

References

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Citations

Feb 3, 2016·Diabetes Technology & Therapeutics·Thomas DanneJan Bolinder
May 15, 2015·Diabetes, Obesity & Metabolism·L HeinemannM Hompesch
Jun 28, 2016·European Journal of Internal Medicine·Luca PasinaAlessandro Nobili
Oct 3, 2015·Journal of Diabetes Science and Technology·Abraham Escobedo-MoratillaAna Paulina Barba de la Rosa
Sep 10, 2015·Journal of Diabetes Science and Technology·Lutz Heinemann
Jan 25, 2017·Diabetes Technology & Therapeutics·Lutz HeinemannSteven V Edelman
Aug 28, 2019·Biomolecules·Eva Rahman KabirMohammad Kawsar Sharif Siam
Nov 25, 2020·Therapeutic Innovation & Regulatory Science·Noraisyah Mohd SaniAdeeba Kamarulzaman
Feb 3, 2021·Preparative Biochemistry & Biotechnology·Anurag S Rathore, Ankita Bhargava

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Methods Mentioned

BETA
glycosylation

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