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Biosimilars Rheumatology Roundup


Regulatory and launch news on rheumatology biosimilars for adalimumab and infliximab was plentiful in February 2021.

During February, the rheumatology space saw several advancements in biosimilars, including 2 Canadian launches, an EU approval, and evidence to support the safety of nonmedical switching.

Adalimumab Launches

Both Sandoz and Fresenius Kabi launched adalimumab biosimilars on the Canadian market. Sandoz Canada’s Hyrimoz is a low-concentration injectable adalimumab indicated for 9 of the 12 conditions of the originator, AbbVie’s Humira. Sandoz said that the launch will be accompanied by a patient support program to arm physicians and patients with reimbursement information, financial assistance, administrative support, and educational materials on biosimilars.

Fresenius Kabi’s adalimumab injectable biosimilar (Idacio) launched the same week as Hyrimoz and is indicated for all 12 conditions approved for Humira. The Canadian division of the German company is managing the launch, which came 2 years after the biosimilar entered the European market, where it faces strong competition from other adalimumab products.

In related developments, Amgen issued a 2020 earnings report showing boosts and setbacks for its rheumatology drugs. Although global sales for Enbrel (reference etanercept) dipped 4% to $5 billion in 2020 due to competition oversees, sales of the company’s adalimumab biosimilar (Amgevita) jumped 54% to $331 million. Additionally, Amgevita is the most prescribed adalimumab biosimilar in Europe despite facing 7 other competitors, Amgen said.

Regulatory Progress

Celltrion Healthcare had a couple of approvals for its biosimilars. Early in February, Celltrion received marketing authorization in Canada for its subcutaneous infliximab biosimilar Remsima (Remsima SC) to treat rheumatoid arthritis (RA). Remsima SC was also approved to be used as part of combination therapy with methotrexate in patients with moderate-to-severe RA.

Celltrion’s adalimumab biosimilar (Yuflyma) received approval for marketing in the European Union, making it the first approved biosimilar to Humira’s high-concentration, citrate-free adalimumab formulation. Although price discounts have yet to be disclosed, Yuflyma gives Celltrion better access to Europe’s very competitive adalimumab market, in which AbbVie has been able to hold 60% market share by converting patients from its original low-concentration formulations to a high-concentration formulation.

Coherus Biosciences made some headway with its mission to get US approval for its adalimumab biosimilar (CHS-1420) when its biologics license application was accepted by the FDA for review. The company has not yet specified the concentration for CHS-1420.

Research on Biosimilar Use

Study results published during February showed the implications of biosimilar use in patients with rheumatic conditions. One study demonstrated a positive safety profile for nonmedical switching between reference infliximab (Remicade) and a Samsung Bioepis infliximab biosimilar (SB2, Renflexis) in patients with inflammatory bowel disease.

The 80-week study was the first long-term trial assessing switching safety for SB2. Findings confirm earlier data that demonstrated full interchangeability regarding immunogenicity between the originator product and SB2 and another infliximab biosimilar, CT-P13, produced by Celltrion.

Another study found that improved access to affordable biosimilars for patients with RA could allow patients to get treatments earlier in the disease cycle. However, investigators said, increased exposure to tumor necrosis factor inhibitors (adalimumab, infliximab, and etanercept) could heighten the risks of immunosuppression and of infection. Careful management is therefore necessary, they said. “The ideal immunological treatment goal is to achieve an immune homeostasis, such that the immune system can respond dynamically and appropriately to the environment.”

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