This year, various domestically produced pharmaceuticals are challenging for approval from the U.S. Food and Drug Administration (FDA). In particular, interest is focused on the FDA approval of a second anticancer drug, which is expected to follow the domestically produced anticancer drug 'RAY' approved by the FDA last year.
According to the Korea Bio Association, the U.S. FDA approved a total of 50 new drugs over the past year. Among them are the domestically produced new drug 'RAY' (generic name lazertinib) from Yuhan Corporation for lung cancer and 'RETIVO', a botulinum toxin (botox) developed by HUGEL.
The industry expects that this year, domestically produced pharmaceuticals developed by corporations will continue to receive FDA approvals. First, the liver cancer treatment 'TULBEGIO' (generic names ribocirumab and camrelizumab), developed by Elevate Therapeutics, a subsidiary of HLB, and China's Ascletis Pharma, is receiving expectations as the 'second RAY'. After the FDA approval was unsuccessful in May last year, it resubmitted the application for approval in September, four months later. The company forecasts that the approval status may emerge as early as March.
There is a reason for the attention on TULBEGIO despite one failed attempt. TULBEGIO is a regimen that combines HLB's ribocirumab and Ascletis Pharma's immune checkpoint inhibitor camrelizumab as a first-line treatment for liver cancer, but the FDA cited issues in the manufacturing process of camrelizumab rather than efficacy or safety of ribocirumab as the reason for its rejection.
Usually, when the FDA points out issues with a drug's efficacy or safety, it takes considerable time for further clinical data verification, but the company explained that TULBEGIO had no such concerns at all. If TULBEGIO clears the FDA hurdle this time, it will become the second domestically produced anticancer drug to succeed in entering the U.S. market, following Yuhan's RAY.
HLB also plans to apply for FDA approval for its cholangiocarcinoma new drug in the second half of the year. Cholangiocarcinoma is a type of cancer that occurs in the bile ducts, which are the pathways for bile produced by the liver. Recently, HLB introduced the cholangiocarcinoma candidate substance 'RLY-4008' from Relay Therapeutics, a U.S. Nasdaq-listed company, through Elevate Therapeutics. It has completed Global Phase 2 clinical trials and has received designation as an innovative treatment and orphan drug from the FDA, allowing it to apply for conditional approval based solely on the Phase 2 results.
An HLB official noted, "We will continue to advance a 'two-track' strategy that expands the indications for ribocirumab while also extending indications for solid tumors including cholangiocarcinoma," and added, "The year 2025 will be a year when HLB formally transforms into a global healthcare corporation through the application for approval of RLY-4008 following the approval of ribocirumab for liver cancer.
HK inno.N's new drug for gastroesophageal reflux disease, K-CAP, is also set to receive FDA approval this year. K-CAP, which is the 30th domestic new drug, has entered 48 countries worldwide, including South Korea, and has already launched products in 15 countries. To facilitate K-CAP's entry into the U.S. market, HK inno.N signed a technology export contract with U.S. pharmaceutical company Braintree in 2021. Braintree is currently conducting a Phase 3 clinical trial for K-CAP for erosive esophagitis in the U.S., planning to apply for FDA approval in the first half of this year with the goal of a U.S. launch in the second half. Erosive esophagitis is categorized as erosive and non-erosive, with erosion referring to a state where the gastric mucosa is damaged.
Domestic biosimilar giants Samsung Bioepis and Celltrion are also challenging for FDA approval for new products this year.
Samsung Bioepis is preparing for approval for two biosimilars of Prolia and Xgeva. Prolia, which will see its patent expire in February in the U.S., is a osteoporosis treatment developed by Amgen and received its initial approval. Subsequently, the active ingredient denosumab was proven effective in preventing bone metastasis complications in cancer patients, and it was approved under the name 'Xgeva' for this indication. The drug recorded global sales of about 8.08 trillion won last year.
Samsung Bioepis received three approvals for biosimilars from the FDA last year, bringing the total number of FDA-approved biosimilar products to eight. The company is considered one of the institutions with the most FDA-approved biosimilars globally, alongside Amgen.
Celltrion plans to apply for FDA approval for a total of four products, including the biosimilar 'IDENZELT' for the treatment of ophthalmic diseases, the autoimmune disease treatment similar 'APTOSMA', the osteoporosis treatment biosimilar 'STOBOCLO', and the asthma and allergy treatment 'OMNICLO'.
A source in the domestic industry noted, "The approval of RAY last year raised expectations for domestically produced anticancer drugs," adding, "With the advent of the Trump administration, a boom in biosimilars is expected, so this year, even more domestically produced new drugs and pharmaceuticals are expected to receive FDA approval compared to last year."