Price of generic drug of Riflimab: What is the difference from the original drug?

Retifanlimab is a new type of immune checkpoint inhibitor developed by Incyte under the trade name ZYNYZ. It has been approved in the United States for the treatment of a variety of malignant tumors, especially Merkel cell carcinoma (MCC) and squamous cell carcinoma of the anal canal (SCAC). As a PD-1 monoclonal antibody drug, its mechanism of action is similar to the widely used nivolumab or pembrolizumab, but it is more targeted in the indication segment. At present, this drug has not been officially launched in mainland China, nor has it been included in the medical insurance catalog, so its clinical use in China is relatively limited.

According to public information from overseas markets, the U.S. versionZYNYZ injection with a specification of 500mg/20ml costs approximately RMB 100,000 per box and is a high-end immunotherapy drug. Since the drug is still under patent protection and there are no legally marketed generic drugs available worldwide, there is no cheaper "generic version". In addition, the threshold for generics of PD-1 monoclonal antibody drugs is relatively high and requires a long period of bioequivalence verification, quality consistency evaluation and rigorous clinical research support, which makes it difficult for generic drugs of Retifanlimab to be released in the short term.

There may be slight differences in biological structure, durability of efficacy, and control of adverse reactions between original drugs and generic drugs that may be launched in the future. Even if they are approved for marketing, clinicians will still prefer original products with rich experience data and clear indications. Original drugs are produced by the original R&D company and have more clinical support. The immunogenicity, pharmacokinetic characteristics and long-term safety of the drug are more transparent.

At a time when domestic patients are looking forward to alternatives to imported drugs, whether Riflimab can be introduced into China as soon as possible and included in medical insurance, or whether a domestic alternative version with more friendly prices will emerge, is a direction worthy of attention in the future. At present, if there is a need for clinical use, it still needs to be obtained through cross-border drug channels under the guidance of professional doctors to ensure treatment effects and medication safety.

Reference materials:https://www.drugs.com/mtm/retifanlimab.html