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Biosimilar Products Provide Additional Options for Medical Care 【發布日期:2020-10-05】 發布單位:藥品組

Biosimilar product is one of the fast-growing types of medicine in the global pharmaceutical market. Increasing the accessibility of biosimilar products can not only provide more treatment options for patients, but also can help lower health care spending by the price competitiveness than the originals. Here are some information about biosimilar products that you need to know.

The definition of a biosimilar product is “a biological product that is highly similar to and has no clinically meaningful differences from an existing regulatory authority approved reference product.” Biological products are produced through biotechnology in living systems. Due to the complex nature of the living systems and manufacturing processes, slight differences are expected between reference products and biosimilar products. Despite the slight differences, biosimilar products behave no clinically meaningful differences from the reference products. Therefore, a biosimilar product can only receive market approval if it demonstrates and proves that its quality, safety, and efficacy (active ingredients, structure and function) are highly similar to the reference product through comprehensive comparative analyses and testing, which include drug structure analyses, functional analyses, identifications, non-clinical studies and comparative clinical studies, etc.

To ensure the safety, purity, and potency (safety and effectiveness), of the biosimilar products have no clinically meaningful differences from the reference products, TFDA has announced several guidance for biosimilar products since 2010 and has established thorough and rigorous review processes. To date, TFDA has been approved 17 biosimilar products in Taiwan, which are growth hormone, insulin, anti-immune rheumatism and anti-cancer drugs.

Biosimilar products enable patients to access innovative medicines and provide more affordable options, without compromising on the efficacy or safety. In order to provide safe and effective biosimilar products, TFDA is committed to continuously improving its review and management system. Moreover, to help the public to understand more about biosimilar products, TFDA has established a biosimilar drug section on the TFDA official website. For more information on biosimilar products, please refer to http://www.fda.gov.tw/TC/siteContent.aspx?sid=11262 .

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