Biosimilars Check-In: Celltrion Pushes for Yuflyma in Europe; Xbrane Updates on Ranibizumab Filing

In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

Yuflyma Launches and Trial Start

According to a report from a Spanish health news source (El Médico Interactivo), Celltrion Healthcare has launched Yuflyma, its adalimumab biosimilar, in the Iberian Peninsula.

Prior to the launches, Celltrion partnered with Kern Pharma Biologics, who will be in charge of the commercialization of Yuflyma in Spain and Portugal. Yuflyma launched in a 40 mg solution in 0.4 mL pre-filled pens for subcutaneous administration. The launch represents the first high-concentration, citrate-free adalimumab biosimilar to become available to Spanish and Portuguese patients.

Celltrion’s partnership with Kern Pharma also includes the commercialization rights for 3 other biosimilars and 1 biobetter: Truxima (rituximab biosimilar), Herzuma (trastuzumab biosimilar), Remsima intravenous (infliximab biosimilar, and Remsima SC (subcutaneous infliximab biobetter).

Yuflyma is indicated for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, ulcerative colitis, Crohn disease, and adult and pediatric uveitis.

In addition to launching Yuflyma in Spain and Portugal, Celltrion has begun recruitment for a clinical trial in France to assess patient adherence and persistence during treatment with Yuflyma.

Yuflyma was approved by the European Commission in 2021 and is available in a high-concentration, citrate-free formulation in France.

For enrollment, patients could have a diagnosis for a variety of rheumatic conditions, including rheumatoid arthritis, ankylosing spondylarthritis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

In the past, some patients on low-concentration adalimumab biosimilar therapy have reported degraded experiences compared with the originator (Humira). Low-concentration adalimumab with citrate can lead to injection site pain and swelling along with bruising.

The study will assess 300 patients and their responses after being switched to a high-concentration, citrate-free biosimilar from the originator or another adalimumab biosimilar. According to Celltrion, the study is expected to conclude by March 1, 2023.

Xbrane Provides Update on Ranibizumab Biosimilar Filing

Xbrane Biopharma received a general advice letter from the FDA recommending for the resubmission of the biologics license application (BLA) for its ranibizumab biosimilar candidate referencing Lucentis, according to a statement from the company.

Previously, Xbrane was asked following a preliminary review to submit additional information before the FDA could accept the BLA for review. The general advice letter, the FDA included comments and based on the time required to complete the BLA, Xbrane said that it plans to resubmit during 2022.

“Xbrane is fully committed to advance its investigational biosimilar candidate towards approval in the United States as quickly as possible to provide a much needed, cost-efficient treatment alternative for patients suffering from severe eye diseases,” the company wrote.

The delayed approval of Xbrane ranibizumab product comes a month after the first ranibizumab biosimilar and the first ophthalmology biosimilar (Byooviz) launched on the US market and after the United Kingdom approved its second ranibizumab biosimilar.