vzphotos/iStock Editorial via Getty Images
- The FDA has approved the supplemental Biologics License Application (sBLA) filed by German family-owned pharma company Boehringer Ingelheim for Cyltezo (adalimumab-adbm).
- Cyltezo is considered as the first Interchangeable biosimilar with Humira (adalimumab), the blockbuster drug marketed by AbbVie (NYSE:ABBV) for autoimmune diseases, including Rheumatoid arthritis.
- After meeting the regulator’s initial criteria, a biosimilar should be supported by an additional clinical study to receive the interchangeable designation.
- According to an IP settlement reached in 2019 between AbbVie (ABBV) and Boehringer Ingelheim, Cyltezo’s commercial license in the U.S. will begin on July 01, 2023.
- Humira made up nearly 43% of AbbVie's (ABBV) total net revenues in 2020. The company has several agreements with adalimumab manufacturers with licensing in the U.S. to begin in 2023. Humira biosimilars entered the European market in 2018.