Key Takeaways
- OTBB Director Sarah Yim said the FDA could have created two classes of biosimilar products, those that are and are not substitutable.
- Agency officials did not adopt the approach, in part, because biosimilars that were not substitutable still raised safety questions.
- As the FDA moves to deem all biosimilars interchangeable, ensuring delivery devices meet the standard remains an open question.
The US Food and Drug Administration’s high biosimilar approval standards appear to have streamlined its ability to deem all of the products interchangeable, should Congress enact the necessary legislation.
Agency officials proposed earlier this year that the interchangeability designation, which requires additional studies to show no efficacy or safety concerns when switching between the reference and biosimilar product,...
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