Regulatory Approvals and Patent Challenges in Pharmaceutical Biotechnology

The field of pharmaceutical goods derived from biotechnology is a burgeoning area of study that involves the use of biotechnology principles in the manufacturing of medicinal substances. The field of biotechnology encompasses a wide range of compounds, including antibodies, nucleic acid products, and vaccines, in the development of several licensed goods available on the market today. Because of the vast, profitable market that generic versions of biopharmaceutical molecules, or “biosimilars,” offer to businesses, there have been many regulations and guidelines published in the last few years related to the product approval pathway. Nevertheless, coordination with international authorities for awarding permissions and constant risk–benefit analysis are required in order to establish effective machinery for initial approval and continued monitoring with a country-specific emphasis. This chapter also covers an important aspect related to the patent of biological origin molecules and its impact on product approval and commercialization. 272 This manuscript provides a general overview of the regulatory approval of biotechnological products and aspects related to patents.