With many patents for commercial biologics expiring in the past 10 years, biopharma companies have reacted by developing biosimilars. Promising broader patient access to critical medicines, potentially lower development costs, and competitive product pricing, it is understandable why so many biopharma companies wish to enter this market.
However, with accelerated growth in the market and reference products (RPs) becoming increasingly complex, developing commercially successful biosimilars is a significant challenge. As many biologics have the same mode of action, introducing a biosimilar to this competitive landscape and gaining a market share requires a full market analysis to select a biologic target with the highest potential for success.
After identifying an opportunity in the market, pricing is just one of many considerations that must be made when developing a product that stands out. Market winners are often those that, depending on the product, will not only be required to match, but rather surpass the patient service offerings of the RP. As a result, biopharma companies with RPs are pivoting their approach to incorporate delivery devices or combination therapies to maintain a market share.
In response to these pressures, many manufacturers are building portfolios of biosimilars within a specific therapeutic area (TA) as opposed to focusing on individual biosimilar products. This option offers potential cost benefits to manufacturers and provides patients with multiple therapeutic options.
Clearly, time is of the essence when bringing a biosimilar to market. Speed to market requires development programs that can operate under compressed timelines. Initial assay development and validation of bioanalytical assays supporting a biosimilar program must also be thorough and complete. This involves incorporating all necessary evaluations to assess critical program characteristics and ultimately allowing for meaningful interpretation of comparability study data. If this cannot be achieved, the product will be late to market, potentially missing the opportunity for success.
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