Exploring Biosimilars: Manufacturing, Regulation, and Future Prospects

The review offers a detailed examination of biosimilars, akin to biologics but more affordable, elucidating their intricate manufacturing and regulatory approval processes. It also delves into the distinctions between biologics, biosimilars, and generics, highlighting the complexities of biosimilar development and the necessity for stringent quality control. Additionally, it provides a comprehensive roster of EMA-approved biosimilar medicines for dermatological conditions, emphasizing their cost-saving potential and enhanced accessibility to advanced healthcare.

Furthermore, the review anticipates the future direction of biosimilars, discussing the advent of “biobetters” aimed at refining therapeutic profiles through structural enhancements. It concludes by addressing the ongoing discourse on biosimilars, recognizing their transformative impact on healthcare and advocating for continued research and innovation to meet the needs of patients with serious ailments.

Reference: Constantin MM, Cristea CM, Taranu T, et al. Biosimilars in dermatology: The wind of change. Exp Ther Med. 2019;18(2):911-915. doi: 10.3892/etm.2019.7505.