Taiwan positions for global biopharma growth as billion-dollar drug patents expire

價值數十億美元的藥品專利到期，台灣在全球生物製藥成長中佔據重要地位

TAIPEI (Taiwan News) — Taiwan’s pharmaceutical industry is positioning itself for greater global competitiveness as the biopharmaceutical sector enters a new phase marked by widespread patent expirations and favorable regulatory reforms.

Between this year and 2034, nearly 50 brand-name drugs, each generating annual sales exceeding US$1 billion (NT$31 billion), are expected to lose patent protection. When a brand drug’s patent expires, manufacturers are permitted to produce versions that are nearly identical to the original in therapeutic purpose, dosage form, safety, effectiveness, method of administration, and quality, according to the Taiwan Generic Pharmaceutical Association.

This wave of expirations presents a significant market opportunity worth tens of billions of US dollars for companies capable of producing generics and biosimilars, which are approved alternatives to brand-name biologic drugs, according to CTEE.

New policies in the US have also made the path to market for biosimilars faster and more cost-effective. Previously, developers were required to conduct lengthy and expensive Phase 1 and Phase 3 clinical trials.

Now, under revised regulations, some biosimilar products need to undergo only Phase 1 trials. This change has shortened development timelines from six to eight years to less than four and reduced development costs by more than 30%.

Among the companies making headlines is Taiwan’s EirGenix, which recently achieved a significant milestone with its breast cancer biosimilar EG1206A. The drug received approval from both the US Food and Drug Administration and the European Medicines Agency to skip Phase 3 trials and proceed directly to the final application stage.

This is the first time a Taiwan-developed biosimilar has reached this stage, placing it among only a handful of biosimilar products globally to do so.

Most biologic drugs are derived from living sources, such as animal cells, bacteria, or yeast, so slight variations may occur between production batches. A biosimilar is a drug approved by regulatory agencies like the FDA that is highly similar to an already approved biologic medicine, according to Taiwan FDA.

While not identical, these minor differences do not affect the drug’s safety or effectiveness. Like traditional generics for chemically synthesized drugs, biosimilars are usually offered at lower prices.

Beyond EirGenix, several other Taiwanese companies are expanding into the biosimilar market. These include Tanvex BioPharma, GlycoNex, Formosa Pharmaceuticals, Oneness Biotech, and Mycenax Biotech.

They are concentrating on biosimilars for high-value therapeutic areas such as breast cancer, diabetes, and obesity. While targeting different diseases, they share a strategy of reverse engineering and advanced bioprocessing to ensure their biosimilars match the quality, consistency, and therapeutic performance of the original biologic drugs.

Tanvex’s TX01 has successfully launched in the US, becoming the first Taiwan-developed supportive cancer therapy approved by the FDA. GlycoNex has completed final dosing for its biosimilar SPD8 in a Phase 3 trial in Japan and plans to unblind results in the second quarter of next year.