The increasing availability of biosimilar medicines in Middle Eastern regions provides an opportunity for patients to have access to traditionally more expensive biologic medicines. However, lack of understanding the development pathway for biosimilars combined with the availability of non-comparable biologics, also known as intended copies, may undermine physician confidence in prescribing legitimate biosimilar medicines. The regulators also need to ensure that biosimilars drugs can be used safely.
Biologics are very complicated molecules, and developing biosimilars is challenging, requiring a step wise approach where the result from each step dictates the requirement in the next step in order to demonstrate similarity. Clinical trials may be required to resolve uncertainties that may remain following non-clinical development. Regulators may also require additional post marketing safety data to ensure that the biosimilar product is safe.
This education training provides an understanding of biosimilar product development pathway and sharing EMA, FDA and MENA regulators’ general approach to the development and approval of biosimilar. The target audience for this course is Pharmaceutical industry, Regulators, health care professionals, physicians, physician assistants, nurses, pharmacists, and pharmacy technicians.