Opportunities and Challenges in Biosimilar Development

Opportunities and Challenges in Biosimilar Development

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. Unlike generic small molecules, it is difficult to standardize such inherently complex products based on complicated manufacturing processes. Table 1 describes the main differences between biosimilar and generic drug molecules.
Table 1: Major difference between biosimilars and generic drugs

The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire (Table 2) and other healthcare sectors focus on reduction of costs. Biologics are among the highest-cost treatments on the global market today, which implies the need for low-cost alternatives. In emerging markets, biosimilars already offer more affordable prices, which are not only attractive, but indispensable to economies where expensive treatments are not financially feasible (1). Interchangeability of biosimilars could have a big impact on drug budgets around the world. However, concerns remain about the effect that could have on patients in terms of safety and efficacy.
Table 2: Patent status of some innovator biologics (3)

Developing and manufacturing biosimilars is challenging, so well-established biopharmaceutical companies are investing in these important medicines. As Table 3 shows, Continue Reading Article