Another Adalimumab Biosimilar Approved Save
On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).
The drug is manufactured by Boehringer Ingelheim, and will be approved for the same indications as Humira, including moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis.
Cyltezo joins amgens Amjevita (adalimumab-atto) as the second adalimumab biosimilar to be approved by the FDA. Nevertheless, neither is likely to hit the market anytime soon as there remains a mountain of litigation to be overcome before commercial use in the USA.
It is estimated that more than a dozen companies are developing adalimumab biosimilars, incuding Samsung Bioepis, Boehringer Ingelheim, Momenta Pharmaceuticals and Sandoz. Other examples of adalimuab biosimilars that have been approved or are in development include:
FDA approved in US
Submitted to EMA
|BI 695501||Cyltezo||Boehringer Ingelheim||FDA approved in US|
|SB5||Imraldi||Samsung||EMA approved in EU|
|GP2017||-||Sandoz||Submitted to EMA|