Zilucoplan launch time and market reference price

Zeleputide (Zilucoplan) was approved by the U.S. Food and Drug Administration (FDA) in December 2023 for the treatment of adult patients with AChR antibody-positive myasthenia gravis (rare disease). This is its first official launch worldwide. Previously, the drug has submitted marketing applications and entered the approval process in many countries in North America and Europe. The launch of zeleptide marks the entry into the era of precise complement inhibition treatment in the treatment of myasthenia gravis, and also meets the urgent needs of patients with poor response to traditional treatments.

In the Chinese market, as of now, Zeleptide has not officially submitted a marketing application to the NMPA (National Medical Products Administration), so it has not been approved for circulation and use, and it has not yet been included in the medical insurance catalog. If domestic patients need to use it, they need to obtain overseas prescription drugs through formal channels, or apply for special approval for use in some tertiary hospitals through the "clinical emergency use" mechanism. As the global launch progresses, it is expected that UCB will launch clinical registration in China in the future and conduct bridging research and commercialization preparations to gradually realize product launch.

From the perspective of market price, Zeleptide, as a new high-cost biological drug, currently has a relatively high public price in the United States. According to overseas drug database information, its subcutaneous injection dosage form is 16.6 mg/0.416 ml, and the price of each tube is about 20,000 to 30,000 US dollars. The specific cost will vary depending on the patient's medical insurance coverage, commercial subsidy plans or medical negotiations. Based on a daily injection, the total annual cost of treatment can be hundreds of thousands of dollars, which is a huge expense for patients who are not reimbursed by health insurance.

Currently, there are no generic drugs of Zeleptide on the market in the world. On the one hand, its patent is still under protection, and on the other hand, its complex peptide synthesis and biologics manufacturing technology threshold is high, which means that there will be no significant price drop in the short to medium term.

Reference materials:https://www.drugs.com/zilucoplan.html