Supporting the Launch of Biosimilars

Examining the regulatory and commercialization strategies essential to the successful launch of a biosimilar.

The global biosimilars market is growing rapidly driven by the rising incidence of chronic disease, patent expirations and an increasing demand for cost-effective medications. Several companies continue to enter this market and have successfully commercialized their biosimilars. This requires a balance of developmental, manufacturing, and commercial tactics to ensure the sustainable launch of products.  

In this series of blogs, experts from Syneos Health will outline the critical success factors required to successfully develop and commercialize a biosimilar asset. These success factors focus on the activities that need to be executed appropriately. This blog will focus on regulatory strategy and commercialization. 

Regulatory Strategy  

Companies should engage and align early with regulatory bodies and plan their filing strategy to reduce the time to approval. Both the EMA and FDA have evolved policies over the last few years, encouraging adoption of biosimilars wherever possible. As a result, a poignant regulatory strategy can shorten time to market and reduce costs. Regular interactions with regulatory agencies can help companies to efficiently design and execute studies that align with the latest regulatory guidance. 

Critical success factors: 

• Think about the totality of evidence needed for approval by that regulatory body. Designations such as interchangeability by the FDA may be obtained without the need for a dedicated switching trial, as an example. 
• Identify the ideal indication(s) for studies, to garner approval AND gain physician adoption (many companies target the former, often forgetting about the latter). 
• Interact early and often with regulatory bodies. This will reduce the probability of an unexpected or late-stage regulatory agency query and mitigate any potential hurdles to approval. 
• Invest to attract and cultivate top-tier talent that is seasoned in engaging with agencies, or external advisory partners who have several years of experience interacting with the appropriate agency. 
• Invest in having mock site visit and third-party reviews of your filing. The cost of a regulatory agency query due to a delay of even one year that could have been prevented can cause the company to be a late entrant in a competitive biosimilar market, which can cost several tens of millions of dollars. 

Commercialization (pricing, contracting and field force solutions) 

The road to commercialization has been a biosimilar manufacturers greatest challenge as it involves a high degree of due diligence and strategic planning prior to launch, as well as an intense focus and coordination once in the market ranging from access to provider and patient focused concerns. The biosimilar market is dynamic and does not evolve like a traditional generics market, often requiring a more in-depth pricing and contracting strategy and greater level of sales and infrastructure investment. Over the near term and course of the next decade manufacturers will need to consider how to develop a successful Go to Market (GTM) strategy.  

GTM Strategy:

 Develop value proposition and identify target market segments (patients, payers, and providers):

• Understand product launch timing and key product differentiators to craft and articulate value to appropriate customer segments.
• Create a value proposition that considers your comprehensive circumstances (product delivery variations, patient services, company heritage, payer positioning, market entry timing, and more).
• Carry through value proposition with effective pull-through from field team(s).

Access: Customize payer strategy with targeted approach that maximizes value across all patients  

• Develop a key access launch playbook for your product, including innovative contracting strategies that allow a manufacturer to compete against the innovator along with prepare for segmented access strategies in priority channels (e.g., commercial versus Medicare) vs other biosimilar competitors. 
• Strategize opportunities for partnership with unlikely partners in an evolving field including payers and specialty pharmacies/distributors.  
• Ensure the appropriate pull-through and optimal timing to maximize opportunities for success. 

Provider: Leverage access strategy to target key provider segments across regions to drive pull through with field force  

• Beyond access, pharma manufacturers need to create a targeted approach with providers for effective pull-through including identifying customer segments ranging from local HCP office to IDNs to community hospitals and their respective carebouts (e.g., reimbursement challenges, hospital review process, purchasing and distribution, and patient support services). 
• Generate effective provider contracting strategies (when applicable) that balance volume expectations and impact product gross to net expectations, including differentiated GPO and 340B pricing strategies.  
• Engage the specialty pharmacy (payer/PBM owned, independent, hospital, or wholesaler) as they continue to play a greater role with exclusive purchasing deals or can provide ancillary services with manufacturers combined with support services (benefit investigation, authorization, hubs and data) as well as logistical coordination (e.g., white bagging). 
• The success of any biosimilar program can be heavily dependent on a proper field force strategy both in terms of spend and experience. Manufacturers must decide whether to leverage existing internal resources or to contract for deployment solutions while balancing tradeoffs in SG&A spend. Historically the most successful biosimilar programs by both small and large cap manufacturers have relied on a field team with established relationships in each customer segment and aligned region.  

Are you looking for the expertise and insight needed to guide your organization’s interest in manufacturing or marketing biosimilars? Explore what expertise the Syneos Health Biosimilars team can offer throughout the entire product lifecycle.     

Are you interested in biosimilar strategy? Reach out to our team:

Michael Sarshad
Managing Director, Consulting

Shane Patel
Senior Consultant, Consulting

Sam Shah
Senior Engagement Manager, Consulting