In the rush to jump on the biosimilars bandwagon aspiring drug developers and manufacturers must understand the needs and views of different stakeholders, including payers, prescribers and patients. Their acceptance of biosimilars as substitutes for brand-name originators will be key to the uptake of biosimilars and the growth of the market. The IMS Health report highlights the different parties whose perspectives are critical, with clinical safety and efficacy being the foremost concern:

• Payers: payers are relatively unfamiliar with biosimilars, which, until now, have had only limited uptake in some countries for particular indications. However, payers’ interest in biosimilars is likely to grow as biosimilars are developed for an increasingly wider range of indications, including diabetes, rheumatoid arthritis and cancer, and as pressure mounts for payers to reduce costs.
• Patients: patients represent an increasingly powerful lobby, they can, however, also be influenced strongly by their physicians’ treatment recommendations.
• Physicians: physicians are likely to step cautiously into the biosimilars arena owing to lack of familiarity and the need for reassurance over the safety and efficacy of these new products.
• Originators and aspiring players: the field is open to all would-be biosimilar R & D enterprises, from small local generics and biotech companies to large multinational pharmaceutical companies. Producers of existing biologicals, however, have various potential strategies for maintaining a hold on the market for existing biologicals. One is to functionally modify them and encourage their use as the standard of care: Amgen’s Neulasta (pegfilgrastim), for example, is a pegylated longer-acting version of Neupogen (filgrastim). Secondly, originators can take advantage of their existing relationships and marketing channels to maintain the loyalty of prescribers and patients. Thirdly, as many recent cases illustrate, lawsuits over patent infringement can delay the entry of biosimilars into the market. In order to enter the biosimilars market, new players will need to invest heavily in sales and marketing in order to win the level of stakeholder confidence that multinationals already have for current and forthcoming products.

In summary, while there is enormous potential gain for many different producers from the future growth of the biosimilars market, the complexity of the field, and the range of stakeholder requirements, means that competition and the investment needed to succeed will be enormous. As the IMS Health report concludes, ‘ultimately, from the heterogeneous group of biosimilars entrants and would-be players, the number of winners may be small.’

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Reference

1.  Shaping the biosimilars opportunity: a global perspective on the evolving biosimilars landscape. IMS Health, December 2011.

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