Author Topic: FDA seeks to clear hurdles for biosimilar insulin in attempt to cut costs for diabetes patients  (Read 501 times)

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Online Elderberry

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Houston Chronicle by  Laura Garcia Nov. 28, 2019

FDA seeks to clear hurdles for biosimilar insulin in attempt to cut costs for diabetes patients

The Food and Drug Administration has been quietly paving the way to bring a cheaper type of insulin to market — an effort that could improve access to lifesaving medication for millions of Americans with diabetes.

The federal agency announced efforts this week to help make the development of “biosimilar” and interchangeable insulin products more efficient, which could ultimately bring them to the market more quickly. Biosimilar insulin mimics the therapeutic effects of brand-name insulins. Interchangeable products are biosimilar products that meet additional guidelines, according to the FDA.

Under the draft guidance released this week, biosimilar drugmakers could skip certain costly clinical trials if they meet certain conditions, including that the proposed product is close enough to one that’s already on the shelves. The guidance clarifies what data and information would be needed to get FDA approval.

More: https://www.houstonchronicle.com/business/health-care/article/FDA-seeks-to-clear-hurdles-for-biosimilar-insulin-14869167.php

Offline Applewood

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Awesome -- provided this "similar" insulin works as well and is safe.