Releasing a memo on a specific case may not be the most effective way to inform industry, but the US Food and Drug Administration’s views on first interchangeable exclusivity are finally available in its resolution of the issue for Boehringer Ingelheim GmbH’s Cyltezo, a biosimilar of AbbVie Inc.’s Humira.
The 18-page memo is only intended to apply to the situation involving Cyltezo and Pfizer Inc.’s Abrilada, a subsequently approved interchangeable biosimilar of Humira (adalimumab)