On June 22, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’ and Biogen’s Imraldi as a treatment for all indications of the reference product, AbbVie’s Humira (adalimumab). With 2016 global sales of approximately $16.1 billion, Humira will face fierce competition from Imraldi, which will offer the second adalimumab biosimilar to patients in the EU if approved by the European Commission (EC).

Humira, which is marketed globally by AbbVie and jointly with Eisai in Japan, is a leading biologic agent that is approved for multiple immunological indications, including rheumatoid arthritis (RA), psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and axial spondyloarthritis. Humira is a recombinant, fully human, IgG1 monoclonal antibody that binds to tumor necrosis factor-α (TNF-α) and blocks its interaction with the p55 and p75 cell-surface receptors, which reduces inflammation and prevents tissue destruction.

In 2016, Humira posted strong annual global sales, making it one of the top-selling pharmaceutical drugs that year. Its rise to the top of the anti-TNF class is due in part to its convenient administration as well as physician and patient familiarity, along with AbbVie’s extensive marketing of the drug. Samsung Bioepis will benefit dramatically if Imraldi is launched in the EU, as Humira generated $5.6 billion in sales outside of the US in 2016 alone.

The CHMP’s positive opinion for Imraldi was based on the clinical development program comparing Imraldi with Humira. A Phase I head-to-head study in healthy volunteers demonstrated pharmacokinetic bioequivalence between Imraldi and Humira. This trial was followed by a Phase III, double-blind, multicenter study in which 544 patients with moderate to severe RA were randomized to receive subcutaneous Imraldi (40mg) or subcutaneous Humira (40mg) every other week for 24 weeks. At Week 24, the primary endpoint, American College of Rheumatology 20 percent (ACR20) response rate, was achieved in 72.5 percent and 72.0 percent of patients receiving Imraldi and Humira, respectively, demonstrating equivalent efficacy. Imraldi also demonstrated a comparable safety and immunogenicity profile to Humira.

Bearing in mind the high annual cost of biologics, particularly for chronic immunological diseases, and the fact that recently launched biosimilars have offered around a 15 percent discount to the price of the originator, Imraldi will not generate the same amount of cost savings for healthcare payers and patients that is typically seen with small-molecule generics. As such, GlobalData anticipates that Imraldi will be priced at a discount of 10–25 percent to Humira across European pharmaceutical markets.

Focusing on the competition within the adalimumab biosimilars segment of the autoimmune space, in March 2017, the EC granted marketing authorization for Amgen’s Amgevita (adalimumab biosimilar) for all indications of the reference product. Further, Samsung Bioepis and Biogen are not alone in the race to bring a Humira biosimilar to the European market. Although Amgen was the first adalimumab biosimilar to gain EU approval, it has yet to launch in the EU, as Humira is patent protected until 2018.

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Meanwhile, Boehringer Ingelheim and Fujifilm’s adalimumab biosimilars are under regulatory review by the EMA, while close to a dozen companies, including Pfizer, Merck, and Momenta Pharmaceuticals, are conducting Phase III clinical trials of their respective adalimumab biosimilars. While Amgen will likely be Samsung Bioepis’ only competition in the Humira biosimilar market upon eventual launch of both products, this will be short-lived as additional adalimumab biosimilars are on the horizon.

That being said, Samsung Bioepis and Biogen have gained approval for Benepali (etanercept biosimilar) and Flixabi (infliximab biosimilar). Imraldi would mark Samsung Bioepis and Biogen’s third anti-TNF biosimilar in the EU. If the drug gains EMA approval, Samsung Bioepis and Biogen would have a biosimilar of all three first-generation TNF inhibitors, setting a strong precedent in the autoimmune biosimilar space.