Thursday, 18 Oct 2018

You are here

Adalimumab Biosimilars Adding Up

Reuters reports that yet another adalimumab biosimilar has been approved by European Union regulators.

The new drug is named Imraldi, and is manufactured by Samsung Bioepis, a company who has several biosimilars approved or in development for worldwide use.

Imraldi is approved in Europe for the the same indications as the originator, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

At the core of biosimilars development is the supposition that increased physician choice and increased competition will create cost savings and increased patient access to biologics. In the EU, TNF therapies are estimated to cost nearly $9 billion. The cost savings from biosimilars in the EU is estimated to be over $11 billion by 2020.

Samsung Bioepis has also received approval by the European Commission for Benepali (an etanercept biosimilar) and Flixab (infliximab biosimilar).

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

SB5ImraldiSamsungEMA approved in EU
GP2017SandozSubmitted to EMA
 BI 695501 -Boehringer Ingelheim In development
 FKB327 - Fuji In development

 

The launch of these biosimilars in the EU and US will likely be challenged in courts where patent litigation is rampant.

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

Add new comment

More Like This

Higher Infection Rates for Infliximab in Psoriasis

A prospective study of psoriasis patients from the British Association of Dermatologists Biologic Interventions Register demonstrated that infliximab therapy yielded 2-3 times more serious infection than seen in those treated with non-biologic DMARDs or methotrexate (MTX).

Biomarker Combo Predicts TNF Inhibitor Responses

Based on clinical trial data, patients starting tumour necrosis factor-alpha inhibitors (TNFi) have roughly a two-thirds chance of achieiving a good clinical response. French investigators have studied a series of potential biomarkers and surmised that the combination of baseline prealbumin, platelet factor 4 and S100A12 can predict a 78% response to TNFi in rheumatoid arthritis (RA) patients.

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.