Tucker Herbert wrote this article.
Disparate uptake of biosimilars to date show that developing a biosimilar is far from a sure bet. Launching any new drug is challenging, but launching a biosimilar can be especially tricky because of the increased uncertainty across regulatory, legal and commercial spheres on one hand and an expectation that significant promotional effort will be required (without being able to differentiate on safety/efficacy) on the other. Is choosing between biosimilars (or an originator) making a therapeutic choice? In the eyes of the FDA, unless a biosimilar has been granted interchangeability, the product choice remains with MDs as the products have been deemed to have equivalent safety/efficacy without being identical. (Other key stakeholders are developing a range of perspectives on this topic.) To ensure commercial success, biosimilar developers (and defenders) need to have a strategic plan for forecasting and conducting market research to fully understand the market complexity. It’s also critical to align the incentives for providers, patients, payers, pharmacists and procurement—all of whom can play a critical role in driving or delaying a new biosimilar’s uptake.
A key shift is occurring in the balance of decision-making power across stakeholder groups. Over the next five years, most revenue targeted by biosimilars will be in oncology, a therapy area where MDs traditionally have wielded the most decision-making authority on product selection before loss of exclusivity (LOE), but play little to no role in deciding between manufacturers once generics become available.
Forecasting biosimilar uptake can be daunting because market events can result in dramatic swings in expected adoption. Unlike in other markets, a biosimilar forecast shouldn’t be an exercise of determining a single share point or uptake curve. Instead, the goal should be to understand the potential scenarios, forecasts that could unfold, the key drivers (both internal and external) that will determine the biosimilar’s success or failure, and the overall potential impact to your (and your competitors’) business.
Market research can identify opportunities where a manufacturer (reference or biosimilar) can influence across stakeholders, but when faced with the biosimilar paradigm shift, many manufacturers have struggled to understand the right questions to ask to truly understand the market complexities. Here are some critical questions to consider:
- Will biosimilars create inflection points leading to growth in patient populations through expanded access?
- How can biosimilars differentiate themselves when clinical differentiation isn’t possible? How much will manufacturing quality and reliability of supply matter?
- What are the key drivers and barriers to uptake across stakeholders?
- What levers are the most successful at encouraging biosimilar adoption?
- What forecasting approach (for example, account- or patient-based) is most appropriate?
- What market analogs or past experiences (such as the Rituxan biosimilar uptake in Canada as an analog for another biosimilar uptake in Canada) will help predict the likely outcomes as a future scenario?
- What key back-end assumptions (such as interchangeability) need to be made in analytics models?
- What are the most successful pricing and (portfolio) contracting strategies in a market with biosimilar competition?
It’s critical that biotech companies address these questions through tailored research techniques and modeling to effectively map the interplay of the incentives for each stakeholder type. Doing so will help shape development strategies that break the mold used in the pre-biosimilar world as these models should help uncover the critical “sensitivities” that will drive a product’s success or failure while market research identifies leverage points that motivate stakeholders even when there isn’t scope to differentiate clinically. Decoding these points can help a manufacturer ensure the best odds of success for their biosimilar bet, or understand when it would be better to pass on certain opportunities.