Biologics and Biosimilars

From 1980, the global pharmaceutical market entered into the golden years of biologics. The rise of biologics brings a major breakthrough in treating incurable diseases. Unlike small molecules, biologicals are very large and intricate molecules that are subject to extensive post-translational modifications that are sensitive to differences in manufacturing conditions. Therefore, biosimilars, the copy versions of biological products whose patents have expired, cannot be exactly same. The regulatory authorities approve the biosimilars by the demonstration of ‘biosimilarity’ comparing to an already approved reference products.

The Characteristics of Biosimilars

It takes enormous time and efforts to maintain the quality of biosimilars, as the manufacturing process is complicated and the requirements of marketing approval are relatively high. Meanwhile, providing affordable biosimilars to markets will facilitate market competition and benefit the whole society with a positive influence on medical expenditure. To lower the prices of biologics and expand the medical resources to more people, many governmental organizations are accepting and applying biosimilars day by day.

The Surveillance of Biosimilars:

To reduce the medical cost and satisfy people’s medical needs, many countries enact regulations for biosimilars and expect more biosimilars to be approved. There are guidelines regarding the regulations of biosimilars in US FDA and EMA. Taiwan government had enacted the guidelines for registration of similar biological medicinal products (SBMP) and biosimilar monoclonal antibodies in order to build a solid foundation for domestic pharmaceutical companies.