Another Adalimumab Biosimilar Approved

Jack Cush, MD

Aug 28, 2017 11:22 am

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:

Name	Trade Name	Manufacturer	Status
ABP501	Amjevita Solymbic	Amgen	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
FKB327	-	Fuji	In development