The Foundations of Success for Biosimilars

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 the first two areas: technical development and manufacturing and clinical development.  

Technical Development and Manufacturing

Technical development and manufacturing capabilities play a pivotal role in enabling biosimilar development teams to establish that their biosimilar products match the reference products with a high degree of similarity. To develop a quality product, companies need to make a strategic choice between carrying out technical development and manufacturing activities in-house versus outsourcing.

In-house development can be an option for companies that are established and have the right resources. However, this decision is as much about the company’s capacity and capabilities as it is about the opportunity to optimize the CMC and production processes and ensuring precision.  

Critical success factors:

• Decide on the cell line to be used as this is pivotal in the development of biosimilars and recognize early whether you have the capacity and competence for cell line development.
• Invest in analytical characterization capabilities and explore opportunities to speed up the process without incurring unnecessary regulatory risks or sacrificing quality through running certain CMC activities in parallel.
• Strike the right balance between creating all in-house capacity and using CMOs; think through whether you have consistent demand and a large enough pipeline to justify owning production and production capacity (or time it will take to ramp up).
• When choosing to use CMOs, it is critical not only to choose the right partner but also to agree on the appropriate level of service upfront.

Clinical Development

It is important that companies develop clear clinical development strategies that allow for filing in an expeditious timeframe while ensuring data integrity. Deeper clinical data will always play a critical role in obtaining regulatory approval and physician adoption, payer support, and patient comfortability with a product, but this needs to be balanced with executing efficient clinical trials.  A proper clinical development strategy can allow biosimilar companies to manage cost, decrease time needed to launch, and position it to maximize launch success, as the speed to market is a key success factor.

Critical success factors:

• Develop clinical strategy to be centered around the needs of regulatory bodies, also factoring in evidence generation needs for downstream reimbursement and access, exchanging efficacy markers over PD markers, aiming to keep trials as lean as possible and exploring the possibility for streamlined studies.
• Evaluate the investment and capabilities required to conduct interchangeability and switching studies, particularly given the changing perception on the overall need for interchangeability and switching studies in the United States.
• Determine your company’s ability and willingness to operationalize trials including designing an effective study protocol and driving patient recruitment. Alternatively identify and outsource to a CRO with global biosimilars experience that can meet your needs and expedite the time for your “molecule-to-market.”
• Identify biosimilar awareness and saturation in the TA which can impact patient recruitment in trials.
• Explore cost-saving opportunities to leverage analytical data for PK bridging studies for reference products across regions

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