……. continuing to catch up on FDA approvals
The FDA recently approved a biosimilar, Simlandi (adalimumab-ryvk) from Alvotech and Teva Pharmaceuticals, as a biosimilar to Humira (adalimumab). Since there are already nine….. yep count ‘em….. other adalimumab biosims already approved, is there anything noteworthy to say about Simlandi…. YES!
The noteworthy thing about this approval is that Simlandi was approved with the coveted interchangeable designation. So, the ability for pharmacist substitution without physician approval in many states gives Simlandi a tangible marketing edge. However, the FDA had already approved Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). The more the merrier?
But wait!…. Simlandi is high-concentration as well as citrate-free giving it a slight marketing edge over its interchangeable competitors….. as well as the rest of the pack.
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FDA Approves Simlandi, Third Interchangeable Humira Biosimilar
