A Biosimilar is a biological medicinal product that is highly similar to an already approved original reference product (a Biologic). There are no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency. Unlike generic drugs, which are chemically identical copies of small-molecule drugs, biosimilars are copies of large, complex biologic molecules made in living systems, making a perfect replication impossible.
The development and approval pathway for biosimilars are highly regulated, requiring extensive analytical, non-clinical, and clinical data to demonstrate “biosimilarity” to the reference product, rather than requiring a full, redundant clinical development program. Once approved, biosimilars offer significant benefits by introducing competition into the market, which can substantially reduce the cost of treating chronic, complex diseases such as cancer and autoimmune disorders. This increased affordability is crucial for expanding patient access to essential, high-cost biological therapies worldwide.
