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Adalimumab Biosimilars Adding Up

Aug 25, 2017 12:30 pm

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:








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.

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

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