Biogen and Samsung Bioepis Launch Humira Biosimilar in Europe

Published on: 

The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

Biogen and Samsung Bioepis announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster biologic, Humira (adalimumab), in an Oct. 17, 2018 press release. AbbVie’s Humira is that company’s top-selling product with $18.4 billion in 2017 sales.  

The launch of Imraldi is the third anti-tumor necrosis factor (TNF) biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe. Benepali (etanercept), referencing Amgen’s Enbrel (etanercept), and Flixabiv(infliximab), referencing Johnson & Johnson’s (J&J) Remicade (infliximab), were approved in 2016, and have approximately 100,000 patients currently under treatment with more than 6 million doses administered across 25 and 14 countries, respectively. Enbrel is Amgen’s top-selling product with $5.4 billion in 2017 sales, and Remicade is J&J’s top-selling drug with $6.3 billion in 2017 sales.

“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, head of Biogen’s Biosimilars Unit, in the company press release.

“The launch of Imraldi marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems. We hope Imraldi will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market,” said Sang-Jin Pak, COO, Samsung Bioepis, in the press release. “In just six years, Samsung Bioepis has successfully developed the industry’s leading portfolio of anti-TNF biosimilars with a strong pipeline of further biosimilar candidates currently under development.”


“We are proud of our collaboration with Biogen, which brings together the development expertise of Samsung Bioepis with the commercial excellence of Biogen for the benefit of patients across Europe,” Pak added.

The European Commission (EC) approved Imraldi in August 2017 for treating rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, and uveitis.

Source: Samsung Bioepis