WebEXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT Cyltezo (adalimumab-adbm) 10 mg/0.2 mL PFS is the first biological product relying on its reference product, to receive a determination of interchangeability for any condition of use. Therefore, with this approval, Boehringer Ingelheim is eligible for a period of first WebOct 19, 2024 · Cyltezo is the first interchangeable monoclonal antibody and only the second interchangeable biosimilar product ever approved by the FDA. Meanwhile, the FDA has already approved 31 biosimilar ...
Cyltezo® (adalimumab-adbm) Shows Equivalence to …
WebDec 31, 2024 · The FDA made Cyltezo (adalimumab-adbm) just the second biosimilar product to gain the coveted interchangeable status, and the first biosimilar to Humira (adalimumab) with this designation. WebOct 20, 2024 · Cyltezo (adalimumab-adbm) is the first FDA-approved interchangeable biosimilar to Humira (adalimumab). It’s the second interchangeable biosimilar to ever be … grand atlas
Revisiting Interchangeability to Realize the Benefit of …
WebOct 18, 2024 · Cyltezo (adalimumab-adbm), originally approved in August 2024, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo's ... WebMay 12, 2024 · Cyltezo is an interchangeable product with Humira. A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the reference product. Cyltezo and Humira are both administered via subcutaneous injection. Cyltezo is available as a single-dose prefilled syringe. WebApr 10, 2024 · In the United States, four biosimilars are designated as interchangeable by the FDA, meaning (subject to any state law) they may be substituted at the pharmacy for the reference product without the intervention of the prescribing health care provider: CIMERLI, a ranibizumab biosimilar of LUCENTIS; CYLTEZO, an adalimumab biosimilar of … china wok sixes road