Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar

The Sandoz adalimumab biosimilar Hyrimoz has been approved by Health Canada for the treatment of 9 rheumatologic and gastrointestinal conditions—in effect, all the indications as for the reference brand, Humira.

Adalimumab is a fully human tumor necrosis factor (TNF) blocker that helps to reduce inflammation. Health Canada granted marketing authorization for Hyrimoz in 3 subcutaneous injection dosage forms: 40 mg/0.8 mL and 20 mg/0.4mL in prefilled syringe, 40 mg/0.8 mL in autoinjector.

The indications include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis.

Sandoz Canada executive Karine Matteau said in a statement that the company intended to launch Hyrimoz by February 15, 2021, and said market potential is promising as 42,000 Canadian patients already receive treatment with adalimumab.

“We are currently working on the reimbursement of Hyrimoz to enable rapid access for patients.” said Matteau, vice president, Bio-Generic Hospital/Physician channel and Head Biosimilars at Sandoz Canada. “Sandoz is dedicated to growing our biosimilars portfolio in Canada and Hyrimoz is an important driver for this in the immunology area, as it complements the recent biosimilar launches we had this year in immunology and oncology.” In Canada, the company markets biosimilars for oncology, immunology, and endocrinology. These compete in a national market that has seen 32 biosimilar approvals to date, Sandoz Canada said.

Sandoz Canada said it would support the rollout with patient support that includes reimbursement navigation, financial assistance, administrative support, and a biosimilar education program for patients.

The regulatory approval for Hyrimoz marks the third approval for the company in Canada over the past 11 months. In August 2020, Sandoz Canada launched the pegfilgrastim and rituximab biosimilars Ziextenzo and Riximyo, respectively. Both agents were approved by Health Canada in April 2020.