Celltrion applies for European approval of Humira biosimilar

Celltrion said Monday that it applied for the European Medicine Agency’s commercialization approval of CT-P17, a Humira (adalimumab) biosimilar.

CT-P17 is a highly potent biosimilar of AbbVie’s autoimmune disease treatment Humira, a blockbuster original that recorded $19.1 billion global revenue in 2019.

If approved, the CT-P17 will be a meaningful addition to Celltrion’s portfolio for rheumatoid arthritis and inflammatory bowel disease treatment, alongside the company’s Remicade (infliximab) biosimilar Remsima. The TNF-alpha inhibitor market these drugs set out to target is estimated to be 50 trillion won ($41.7 billion) in size, globally.

Celltrion expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.

“We believe the CT-P17 has differentiated value from existing Humira biosimilars, with high market expectations. We will do our best for an early market release of the pipeline,” Celltrion said.

Due to its high potency, CT-P17 can have its targeted effect with less amount of injection than the original. The drug is citrate-free, meaning it causes less pain upon injection.

Celltrion had previously vowed for an annual of output of minimum one biosimilar up to year 2030.

Apart from CT-P17, Celltrion is also carrying out phase 3 clinical trial of Genetech’s Avastin (bevacizumab) biosimilar CT-P16 for metastatic colorectal cancer, metastatic breast cancer and non-small cell lung cancer indications.

For Novartis’ asthma and rash treatment Xolair (omalizumab) biosimilar, CT-P39, the company is in the research phase.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)