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It is an exciting time in the advancement of biosimilar medicines technology and treatments for patients. Over the past few years, great progress has been made in the development and approval of more affordable biosimilar versions of innovative therapies that treat some of the most debilitating and serious health conditions. In 2010, to encourage greater uptake of biosimilars, the FDA implemented an abbreviated pathway for approval of biosimilar and interchangeable products. Instead of independently demonstrating safety and effectiveness, the manufacturer must demonstrate that its proposed product is biosimilar to, or interchangeable with, an FDA-approved reference product. The FDA noted the following in regards to biosimilars:
• A biosimilar is a biological product • A biosimilar is highly similar to a reference product • A biosimilar has no clinically meaningful differences from a reference product • A biosimilar is approved by the FDA after rigorous evaluation and testing by the applicant
The FDA’s hope is that an efficient path for demonstrating product interchangeability with brands will help build prescriber and patient confidence in switching to biosimilars. To learn more please visit the FDA’s What is a Biosimilar?
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