Five Strategic Considerations for Biosimilar Commercialization
By Rohit Sood, Sebastien Morisot, and Rafal Kokolus
With a large number of blockbuster biologics such as Erbitux [cetuximab; ImClone, BMS] and Herceptin [trastuzumab; Genentech] expected to go off-patent in the next 5 years, the global biosimilar market is expected to reach $15 billion by 2020. More than 150 manufacturers are currently investing in biosimilar development, manufacturing, and commercialization capabilities across several key markets, including South Korea, India, China, Argentina, and in the European Union (EU). Meanwhile, advancements in technology and capabilities as well as economic necessities driving the need for less expensive medicines have created an opportunity for biosimilars in the marketplace.
Biosimilar commercialization is essentially similar to commercializing a biologic, but with two key differences: the level and mix of the investment and the commercial model. Through our research and experience working with a wide range of commercial organizations in the biotechnology space, Campbell Alliance has identified five factors companies may consider as they think about commercializing biosimilars: country, category, company, competition, and customer.
In determining the countries in which a product will be marketed, consideration must be given to different levels of IP protection, regulatory pathways, and policies on interchangeability/ automatic substitution.
In Europe, biosimilar products for growth have been available for almost a decade. To push back, manufacturers of originator drugs are using changes in manufacturing procedures and formulations to create new patent protections. As they begin to invest in the development of new biosimilars, manufacturers may consider engaging outside council to conduct a patent mapping exercise to make sure that there is a development path with minimal barriers. IP mapping is vital for addressing not just the known IP implications of a product but also the potential unknown issues.
Meanwhile, policies around interchangeability and automatic substitution differ by region (Figure 1a and 1b). In the EU, decisions regarding interchangeability are decided by the individual countries. Due to concerns around the traceability of adverse events, almost all EU country regulatory bodies have established rules against automatic substitution.1 However, there is some change on the horizon.
In January, France became the first country to allow pharmacists to substitute a biosimilar for a “reference biologic.” In Germany, a large proportion of erythropoietin is apparently being purchased by dialysis clinics through a physician organization equivalent to a group purchasing organization, so physicians there appear to have direct financial incentive to use the less expensive product. In fact, German physicians run the risk of being held accountable for exceeding target cost limits in prescribing, which is driving uptake for biosimilars. Italy, Spain, and the UK have established guidance and official lists of non-substitutable medicines that include all biologics.
Here, in the US, legislation regarding biosimilars varies from state to state and is constantly evolving. Virginia, Utah, and North Dakota have passed laws that permit pharmacists to dispense a biosimilar in place of a prescribed biological product only if that biosimilar meets the higher safety standards for interchangeability. Meanwhile, states like Arizona, Maryland, Mississippi, and Washington have rejected similar laws. Numerous other states have legislation that is expected to be considered.