Celltrion said it would release the results of phase 3 trials of two biosimilars at two European conferences in September.

The two biosimilars are CT-P43 referencing Stelara (ingredient: ustekinumab) and Vegzelma (bevacizumab) referencing Avastin.

Celltrion will release the results of phase 3 trials of two biosimilars, CT-P43 and Vegzelma, in Europe next month.
Celltrion will release the results of phase 3 trials of two biosimilars, CT-P43 and Vegzelma, in Europe next month.

During the 31st European Academy of Dermatology and Venereology (EADV) Congress, Celltrion will present the global phase 3 study results that evaluated the safety and efficacy of CT-P43 in patients with plaque psoriasis at the late-breaking news session.

The meeting of EADV is Europe’s largest dermatology event, which will be held in Milan, Italy, from Sept. 7-10

Stelara, the original drug, was developed by Janssen to treat autoimmune diseases, including psoriasis, Crohn’s disease, and ulcerative colitis.

According to Johnson & Johnson’s business report, Stelara sold $9.13 billion in 2021.

At the European Society for Medical Oncology Congress (2022 ESMO Congress) in Paris on Sept. 9-13, Celltrion will also present the outcome of the global phase 3 trial of Vegzelma (pipeline name: CT-P16), which recently won marketing approval in Europe.

At the upcoming event, Celltrion will present data confirming the similarity in survival and safety results of the clinical trial that compared Vegzelma with the original drug Avastin.

On Aug. 18, Celltrion obtained approval for Vegzelma from the European Commission to treat multiple cancers, including metastatic colorectal cancer and non-small cell lung cancer (NSCLC), which were previously authorized for Avastin.

Before winning the permit for the bevacizumab biosimilar, Celltrion completed the agreement with the original drug developer on the global patent of the drug.

Celltrion Healthcare, which distributes Vegzelma in the global market, plans to roll out the drug in Europe in the year's second half.

Roche developed the original Avastin, a blockbuster anticancer drug to treat NSCLC, metastatic colorectal cancer, metastatic breast cancer, and glioblastoma.

According to IQVIA, a global pharmaceutical market research firm, bevacizumab sold about $6.41 billion in 2021.

An official at Celltrion emphasized that the company was leading the European biosimilar market thanks to the success of Remsima (infliximab) and Truxima, which sells even more than the original drugs, and the rapid growth of Remsima SC.

“We will do our best at the group level to commercialize next-generation growth items Vegzelma and CT-P43, to be introduced in Europe in September so that European patients can access them,” he said.

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