Friday, 19 Jan 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

Why TNF Inhibitors May Work in Some Autoinflammatory Patients

The NLRP3 inflammasome is a critical component of the innate immune system and activation of NLRP3 inflammasome results in caspase-1–dependent secretion of the proinflammatory cytokines IL-1β and IL-18. Gain-of-function missense mutations in NLRP3 is thought to drive many of the autoinflammatory diseases, especially the cryopyrin-associated periodic syndromes (CAPS).

Infliximab Does Not Increase Perioperative Infection

Staying on a TNF inhibitor (TNFi) throughout major surgery has generatlly been associated with higher rates of perioperative infection (https://buff.ly/2iBFVjp).  On the other hand, discontinuation of the TNFi prior to surgery is associated with lower rates of  infection (https://buff.ly/2iAFZQf)

CALM Study: Tight Control with Anti-TNF Wins in Crohn's Disease

Not unlike rheumatoid arthritis and other inflammatory disorders, therapeutic efficacy in Crohn's disease (CD) is often assessed clinically. There is growing use and interest in biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein. But Lancet has now reported a clinical trial has shown that a tight control strategy can yield better responses to TNF inhibitors when compared to usual care. 

Amgen-Abbvie Settle Humira Biosimilar Patent Dispute

Amgen's biosimilar version of adalimumab (Humira) was FDA-approved in September 2016 and given the trade name Amjevita (generic: adalimumab-atto). This new TNF inhibitor biosimilar has not yet been to market because of legal wranglings over patent issues by Abbvie's Humira.

Another Adalimumab Biosimilar Approved

On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).