Celltrion Healthcare shared positive 1-year results from a phase 3 trial evaluating the safety and efficacy of its high-concentration adalimumab biosimilar (Yuflyma, CT-P17) compared with the reference product (Humira) in patients with moderate-to-severe active rheumatoid arthritis (RA).
The high-concentration, low-volume, citrate-free formulation features an ultra-fine needle that allows for less discomfort and pain and better treatment adherence in patients. The results were presented at the Annual European Congress of Rheumatology 2021.
“Demonstration of equivalent efficacy and comparable safety of CT-P17 to EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar,” said Jonathan Kay, MD, lead investigators and a professor at the University of Massachusetts Medical School, in a statement.
The randomized, double-blind study enrolled 648 patients with active moderate-to-severe RA who did not have success with methotrexate therapy. The patients were randomized to receive either 40 mg of CT-P17 or reference adalimumab every 2 weeks up to 24 weeks.
At week 26, 608 patients were randomized again to maintain their treatment or switch from the reference product to the biosimilar up to week 48, resulting in 303 patients continuing therapy with the biosimilar, 153 patients continuing therapy with the reference product, and 151 patients switching from the reference product to CT-P17.
Pharmacokinetic levels were maintained after 24 weeks in all treatment arms and the safety profiles were comparable between the groups. All groups had a similar proportion of treatment-emergent adverse events occur, with neutropenia being the most reported.
Regarding immunogenicity, the amount of anti-drug antibodies and neutralizing antibodies were similar between the CT-P17 maintenance group (28.4% and 24.8%, respectively), the reference product maintenance group (27.0% and 24.3%, respectively), and the group switched to a biosimilar (28.3% and 26.3%, respectively).
The trial results come after CT-P17 was granted marketing authorization from the European Commission in February 2021.
Additionally, the company announced that its subcutaneous infliximab biosimilar (Remsima SC) received approval from the European Commission for use without intravenous infusion for new and existing patients with RA.
“Celltrion now has biosimilars of both infliximab and adalimumab with value-added features, and thus CT-P17 could be used sequentially with Remsima SC to bring clinical benefit for chronic diseases which require long- term treatment,” said HoUng Kim, PhD, head of medical and marketing division at Celltrion Healthcare, in a statement.
Celltrion and Alvotech are positioning themselves to be leaders in the high-concentration adalimumab biosimilar space and some experts are concerned that product differentiation by concentration will threaten the 6 adalimumab biosimilars approved in the US that have not launched.
In May, Alvotech filed a US federal lawsuit against reference adalimumab manufacturer AbbVie, alleging that AbbVie has abused patent laws in order to keep its adalimumab monopoly in the US, where no adalimumab biosimilars are able to enter the market until 2023.
Celltrion’s CT-P17 was submitted for approval to the FDA in November 2020 and the company is expecting to expedite the launch process for France, Germany, Italy, Spain, and the United Kingdom, according to Kim.