The sBLA was based on data from a clinical study assessing the pharmacokinetics of switching between adalimumab and adalimumab-bwwd for patients with moderate to severe plaque psoriasis.
The biosimilar landscape is growing, but the FDA should leverage analytical data to efficiently determine the quality of these products and propel them toward approval, according to a session at the Academy of Managed Care Pharmacy’s Nexus 2023 conference.
The FDA is the only authority that can designate a biosimilar as interchangeable with its reference product, which requires that the product has similar clinical results for the same indication.
Jensen notes that although she expects there will be a lot of FDA approvals in 2023 and 2024, there likely will not be another biosimilar “boom” until 2025.
Pharmacy Times will be providing exclusive session coverage and interviews with presenters for the Academy of Managed Care Pharmacy Nexus 2023 conference.