Thursday, 19 Jul 2018

You are here

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

Add new comment

More Like This

TNF Inhibitors Don't Increase Cancer Risk in Children

While the risk of neoplasia with tumour necrosis factor inhibitor (TNFi) use has been largely nullified in most inflammatory disorders, this risk in children is less certain. However a recent study shows no risk of increased cancer in children treated with TNFi for juvenile idiopathic arthritis (JIA), pediatric inflammatory bowel disease (pIBD) and pediatric plaque psoriasis (pPsO).

Risk of Psoriasis Complicating TNF Inhibitor Therapy

A population-based study of claims data from Korea shows that among inflammatory bowel disease (IBD) patients receiving tumour necrosis factor inhibitors (TNFi) there is a 3.7 per 100 patient-year risk of paradoxically developing psoriasis - a rate that is roughly 3-fold higher than risk in TNFi-naive IBD patients.

Favorable Certolizumab Safety Profile in Pregnancy

Clowse and colleagues have published an extensive review of the certolizumab pegol (CZP) in pregnancy database, and found no evidence that CZP has a teratogenic effect or contributes to fetal harm when compared to the general population. 

Severe Stevens-Johnson and Toxic Epidermal Necrolysis Syndromes May Respond to Etanercept

The Journal of Clinical Investigation reports the results of a trial wherein etanercept (ETN) was shown to be effective in treating cytotoxic T lymphocyte–mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Pediatric Use of TNF inhbitors Does Not Increase Malignancy Risk

A study of USA administrative claims data between 2000 to 2014 assessed the risk of cancer with exposure to tumour necrosis factor inhibitor (TNFi) in pediatric patients and found that TNFi therapy did not significantly increase the risk compared those not receiving TNFi.