In recent years, public awareness of healthcare and medication safety has grown significantly. As a result, many people often ask, "Are generic drugs effective?" and "Are biosimilars safe to use?"
In fact, both generic drugs and biosimilars must undergo rigorous regulatory review by health authorities to ensure their quality, safety, and efficacy before gaining market approval.
The key difference among brand-name drugs, generic drugs and biosimilars are defined below:
- Brand-name Drugs (Original Drug): Medicines developed and patented by pharmaceutical companies. During the patent protection period, the companies have exclusive rights to manufacture and market these medicines.
- Generic Drugs: Once the patent for a brand-name drug expires, other pharmaceutical companies may manufacture generic versions. Generic drugs contain the same active ingredient(s), dosage form, and strength as the brand-name drug, offering equivalent therapeutic effects.
- Biosimilars: Biologics (large-molecule biological medicines) whose active ingredients are highly similar to an approved reference biological product, with no clinically meaningful differences in safety and efficacy.
The adoption of generic drugs and biosimilars not only provides patients with broader treatment options and improves access to essential medicines, but also strengthens the resilience of the pharmaceutical supply chain. Furthermore, savings generated from these cost-effective alternatives allow the National Health Insurance Administration (NHIA) to allocate limited NHI resources toward innovative therapies and advanced healthcare services, ultimately benefiting a greater number of patients.
For more information, please visit:
- Official website of the Taiwan Food and Drug Administration (TFDA): https://www.fda.gov.tw/TC/index.aspx
- Information section for biosimilars and generic drugs: https://gov.tw/Adc