Canada Sees Second Adalimumab Biosimilar Launch in a Week

Fresenius Kabi has launched an adalimumab injectable biosimilar (Idacio) in Canada, the company said in a statement. The product, which marks Fresenius Kabi’s first North American biosimilar launch, is approved for all 12 indications of the reference product, Humira, in Canada.

Those indications are rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, adult and adolescent hidradenitis suppurativa, adult and pediatric Crohn disease, ulcerative colitis, adult noninfectious uveitis, and pediatric chronic noninfectious anterior uveitis. Health Canada issued approval for the biosimilar on October 30, 2020.

Fresenius Kabi’s global headquarters are in Bad Homburg, Germany, although it operates a Canada division that is managing this launch.

The Canada launch marks the second for an adalimumab biosimilar this week. Sandoz launched Hyrimoz, also an injectable biosimilar, which is indicated for 9 of 12 indications of the originator product.

Idacio has been available in Europe since 2019, although in a low-concentration formulation that faces strong competition from other adalimumab biosimilars and a high-concentration version of adalimumab introduced by AbbVie, the originator company.

Fresenius Kabi Pipeline

In its pipeline, Fresenius Kabi is developing a tocilizumab biosimilar, referencing Actemra, which is for the treatment of severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. The company also is developing a pegfilgrastim biosimilar, a supportive care product for the treatment of patients undergoing chemotherapy and vulnerable to infection.

Canada is considered an increasingly fertile territory for biosimilar distribution, given the country's embrace of these lower-cost medicines through the development of policies that give preference to biosimilar use. Earlier this month, Celltrion received Health Canada approval for a subcutaneous infliximab biosimilar (Remsima) for the treatment of rheumatoid arthritis.

Also, in November, Alberta, the fourth largest province in Canada, reported early success with a biosimilar switching program. According to Graham Statt, assistant deputy minister of the Pharmaceutical and Supplementary Benefits Division for Alberta Health, 30% of patients receiving infliximab in Alberta had switched to a biosimilar since December 2019. And in general, the province had succeeded in switching 16% of patients from 7 costlier reference products. Alberta is aiming for biosimilar savings approaching $200 million over the next 4 years.