South Korean biotechnology company Celltrion announced two new data sets on the subcutaneous formulation Remsima (infliximab) in a number of conditions in March 2022. This followed the February 2022 announcement that the high-concentration version of Celltrion’s autoimmune disease biosimilar Yuflyma (adalimumab) has received approval from the European Commission.
Remsima new data
The company’s REMSWITCH study investigated the clinical and pharmacological impact of switching from intravenous (IV) to a subcutaneous (SC) formulation of Remsima in patients with inflammatory bowel disease (IBD), to evaluate the feasibility of switching and to determine the equivalence between the two types of doses.
Results showed switching patients from IV to SC Remsima is feasible, well-accepted and leads to a low risk of relapse in patients with IBD.
Adalimumab biosimilar approval in Europe
On 11 February 2022, the European Commission granted marketing authorization for Yuflyma, an adalimumab biosimilar, across all 13 intended indications for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis and psoriasis. Yuflyma is a biosimilar of AbbVie Inc’s blockbuster drug, Humira. Administration of Yuflyma can be advantageous to patients as it requires only half the solution administered to patients compared with the existing Humira biosimilar and is also citrate-free, which lessens discomfort during injection.
The approval follows Yuflyma’s approval in Canada in January 2021 [1]. Yuflyma now joins a host of other Celltrion biosimilars available in Europe [2], the first of which was Remsima approved in 2013 [3]; with Remsima SC – the only SC formulation of infliximab available – launched in Europe in early 2020 [4].
Record Remsima sales in the US
Sales of Celltrion’s Remsima to treat autoimmune diseases in the US increased by 13% on-year to US$385 million in 2021.
Remsima was first launched in the US in 2016 and is a biosimilar of Janssen Biotech Inc’s Remicade and is used to treat various diseases, from rheumatoid arthritis to Crohn’s disease [3]. In the US, Pfizer is responsible for sales of the biosimilar drug under the name Inflectra. The product now has almost a quarter of the US market and has been influential in reducing sales of Remicade, which have reduced from US$4.5 billion to US$2 billion in the last five years.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Canada approves adalimumab biosimilars Simlandi and Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/biosimilars/news/canada-approves-adalimumab-biosimilars-simlandi-and-yuflyma
2. GaBI Online - Generics and Biosimilars Initiative. Advances for biotech in Korea Samsung Bioepis Celltrion and lg-Chem [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/biosimilars/general/advances-for-biotech-in-korea-samsung-bioepis-celltrion-and-lg-chem
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/biosimilars/news/EMA-approves-first-monoclonal-antibody-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion launches infliximab biosimilar Remsima SC in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 8]. Available from: www.gabionline.net/biosimilars/news/Celltrion-launches-infliximab-biosimilar-Remsima-SC-in-Europe
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