Monday, 26 Aug 2019

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Another Adalimumab Biosimilar Approved

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

ManufacturerStatus
ABP501

Amjevita

Solymbic 

Amgen

FDA approved in US

Submitted to EMA

BI 695501 CyltezoBoehringer IngelheimFDA approved in US
SB5ImraldiSamsungEMA approved in EU
GP2017SandozSubmitted to EMA
 FKB327 - Fuji In development

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

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