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An In Ovo Model for Testing Insulin-mimetic Compounds
Published on: April 23, 2018
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Introduction of biosimilar insulins in Europe
Summary
Biosimilar insulins, like insulin glargine, offer safe and effective diabetes treatment options. Regulatory approval ensures they are not meaningfully different from reference products, potentially increasing access and reducing costs.
Area of Science:
- Biotechnology
- Pharmacology
- Endocrinology
Background:
- Biosimilar insulins, such as LY2963016 (Abasaglar®) and MK-1293 (Lusduna®), have gained regulatory approval, expanding treatment choices for diabetes management.
- Unlike chemically synthesized drugs, biosimilar insulins are complex biological products that cannot be identical to their reference counterparts.
- Stringent regulatory guidelines are essential to ensure the safety and efficacy of biosimilar insulins.
Purpose of the Study:
- To explain the concept of biosimilar medicines.
- To outline the regulatory requirements for registering biosimilar insulins in Europe.
- To review the development and approval process of biosimilar insulin glargine products.
Main Methods:
- Preclinical comparative studies, including in vitro bioassays for receptor binding and biological activity.
- Clinical phase I studies evaluating pharmacokinetic/pharmacodynamic profiles.
- Clinical phase III studies assessing long-term safety and efficacy.
Main Results:
- Biosimilar insulins undergo rigorous testing to demonstrate comparable safety and efficacy to reference products.
- Regulatory frameworks ensure that biosimilar insulins meet high quality standards.
- Successful development of LY2963016 and MK-1293 insulin glargine illustrates the regulatory process.
Conclusions:
- Biosimilar insulins provide safe and effective therapeutic alternatives.
- The availability of biosimilar insulins can enhance access to modern insulin therapies.
- Biosimilar insulins have the potential to increase treatment personalization and reduce healthcare costs.
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