As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.
As Celltrion releases new data on its subcutaneous infliximab product, Samsung Bioepis secures an interchangeability designation for Byooviz (ranibizumab-nuna), making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.
Byooviz has become the second ranibizumab/ophthalmology biosimilar to receive an interchangeability designation. The news comes a little over a year after Cimerli, Coherus Biosciences’ ranibizumab product, was granted interchangeability in August 2022.
The FDA approved Byooviz as the first ranibizumab/ophthalmology biosimilar to Lucentis (reference ranibizumab) in September. Ranibizumab products are vascular endothelial growth factor inhibitors used to treat several ophthalmic conditions, including age-related macular degeneration, macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
To obtain the designation, the FDA requires information that shows that “the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and its reference product is not greater than the risk of using the reference product without such alternation or switch.”
In most cases, this is demonstrated with data from a switching study, where patients are switched back and forth several times between the reference product and biosimilar to prove that transitioning is safe and doesn’t impact clinical outcomes. However, Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, said that the intravitreal administration of ranibizumab products doesn’t warrant the need for a switching study because there is a low risk of immunogenic response within the eye.
Byooviz was developed by Samsung Bioepis and is marketed in the United States by Biogen. The companies have been in an exclusive commercialization agreement for Byooviz and SB15, an aflibercept candidate, since November 2019.
Celltrion Data on Subcutaneous Infliximab
At the United European Gastroenterology Week 2023, Celltrion shared updated data from its phase 3 LIBERTY trials assessing the use of the company’s subcutaneous infliximab product (CT-P13 SC) in patients with inflammatory bowel disease (IBD), an umbrella term for ulcerative colitis (UC) and Crohn disease (CD).
The study results demonstrated that CT-P13 SC has a similar safety profile to the placebo during the maintenance period (54 weeks). The proportion of patients who experienced adverse events, serious adverse events, inflection in both treatment arms were comparable. No new safety concerns were identified.
Additionally, results from 2 post-hoc analyses were presented. The first examined the possible use of CT-P13 SC treatment without immunosuppressants, showing that use of the product as a monotherapy was safe for patients with UC and CD, suggesting that combination therapy with CT-P13 and immunosuppressants would have little benefit for these patients.
The second analysis assessed dose escalation in patients with loss of treatment response. The recommended dose for CT-P13 SC is 120 mg once every 2 weeks. Exploratory results suggest that dose escalation from 120mg to 240mg every 2 weeks may restore efficacy, while safety profiles were shown to be comparable between patients with or without dose escalation. In both studies, patients showed improvement in terms of clinical remission (UC: 24.7%, n = 20/81; CD: 53.8%, n = 21/39) or endoscopic response (CD: 28.2%, n = 11/39) after dose escalation.
Celltrion also presented real-world data on switching from its intravenous infliximab biosimilar to CT-P13 SC in a separate presentation at the conference. “The findings may help support the practical application of this innovation,” Celltrion wrote.
The product was based on Celltrion’s infliximab biosimilar (Inflectra; infliximab-dyyb) and is the only subcutaneous infliximab in the world. Earlier this week, the FDA approved the product and it will be marketed as Zymfentra, which is also available in the European Union as Remsima SC.
“As a healthcare professional dedicated to improving the lives of IBD patients, I am excited to see further data that validate a subcutaneous treatment option allowing more patients in the U.S. to have greater control of their disease,” Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern Medicine, and professor of medicine at the Feinberg School of Medicine, said in a statement from Celltrion.