Pharmaceutical Executive November 10, 2023
Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) is seeking to become the third Humira biosimilar deemed interchangeable with the reference product.
The FDA has accepted a Supplemental Biologics License Application (sBLA) for interchangeability designation for a new adalimumab (Humira) biosimilar, adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) injection 40 mg/0.4 mL.
Earlier this year, the FDA granted interchangeability designation to adalimumab-afzb (Abrilada), which was the second Humira biosimilar deemed interchangeable behind adalimumab-adbm (Cyltezo), the only other adalimumab biosimilar with granted interchangeability. Abrilada was the fifth biosimilar overall granted the interchangeability designation.
“Following our announcement on the interchangeability study’s topline results in August, we are excited to share the progress on this sBLA filing on...
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