Do biosimilars require FDA approval?
Do biosimilars require FDA approval?
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety (and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.
What biosimilars are approved in US?
FDA-Approved Biosimilar Products
| Biosimilar Name | Approval Date | Reference Product |
|---|---|---|
| Riabni (rituximab-arrx) | December 2020 | Rituxan (rituximab) |
| Hulio (adalimumab-fkjp) | July 2020 | Humira (adalimumab) |
| Nyvepria (pegfilgrastim-apgf) | June 2020 | Neulasta (pegfilgrastim) |
| Avsola (infliximab-axxq) | December 2019 | Remicade (infliximab) |
What is the approval process for biosimilars?
What is the approval process for biosimilar products? All FDA-approved biological products, including reference products and biosimilar products, undergo a rigorous evaluation so that patients can be assured of the efficacy, safety, and quality of these products.
What is biosimilar FDA?
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
How does a biosimilar get approved?
A biosimilar is approved by FDA after rigorous evaluation and testing by the applicant. Prescribers and patients should have no concerns about using these medications instead of reference
Which are biosimilars interchangeable?
Biosimilar Interchangeability: 9 Things to Consider An interchangeable biosimilar is expected to produce the same clinical result as the reference in any given patient. The Federal Drug Administration’s (FDA) official guidance on interchangeability is still in draft form. There are currently no FDA-approved interchangeable biosimilars.
Are any biosimilars interchangeable in the US?
There are currently no interchangeable biosimilars in the US market, but several states are rushing to enact laws that will impact how pharmacies provide these medications.