Taiwan is becoming a key player in the global biosimilar market. This is due to major drug patents expiring. Consequently, new opportunities are opening for Taiwan’s pharmaceutical industry. Nearly 50 blockbuster drugs will lose patent protection by 2034. As a result, Taiwan’s drugmakers are preparing to expand globally.
Between now and 2034, many brand-name medicines earning over US$1 billion annually will lose exclusivity. This letsmanufacturers produce biosimilars. These are highly similar to original biologic drugs. The Taiwan Generic Pharmaceutical Association says biosimilars match originals in safety, effectiveness, and quality.
Moreover, recent U.S. regulatory changes have sped up biosimilar approvals. Before, developers needed Phase 1 and Phase 3 clinical trials. This made development long and costly. Now, some biosimilars only need Phase 1 trials. This cuts development time from eight years to under four. Also, costs dropped by over 30%.
Taiwan’s EirGenix made headlines with its breast cancer biosimilar EG1206A. Remarkably, it skipped Phase 3 trials. The drug moved straight to final approval by the US FDA and European Medicines Agency. This is a first for Taiwan. It ranks the product among a few worldwide.
Since most biologic drugs come from living organisms, batch variations occur. Still, biosimilars maintain high similarity. Small differences do not affect safety or efficacy, says Taiwan’s FDA. Usually, these drugs cost less than originals.
Besides EirGenix, many Taiwanese firms grow in biosimilars. Companies like Tanvex BioPharma, GlycoNex, Formosa Pharmaceuticals, Oneness Biotech, and Mycenax Biotech focus on breast cancer, diabetes, and obesity. They use reverse engineering and advanced bioprocessing. This ensures their biosimilars meet original drug standards.
Tanvex broke new ground by launching TX01 in the US. It is Taiwan’s first FDA-approved supportive cancer therapy. Meanwhile, GlycoNex finished dosing in a Phase 3 trial for SPD8 in Japan. Results will come next year.
Experts highlight Taiwan’s good timing entering the biosimilar market. Indeed, patent expirations and easier regulations create a rare growth window. As a result, Taiwan’s pharmaceutical sector may rise globally.
Looking ahead, Taiwanese firms plan to speed product development and approvals. Overall, the biosimilar market promises more innovation, lower costs, and better patient access. Therefore, Taiwan’s investment and expertise set it up for long-term success.
