With patents rapidly expiring on branded biologics, the biosimilars industry is expected to blossom in the coming years. Analysts predict the global biosimilars market may reach as high as $6.22 billion by 2020, up from $2.29 billion in 2015. But the time and financial investment needed to develop and market a biosimilar is significant, taking an estimated seven-to-eight-years and costing between $100 million and $250 million.

The market appears to holds considerable growth potential, particularly for companies that figure out how to accelerate these trials so they can be first to market. A key to that speed is more efficient recruiting for Phase I trials.

Biosimilar drug development is different because the Phase I clinical trials required for registration are primarily for comparability of the pharmacokinetic profiles. Due to the variability inherent in many originator biologic compounds, most of these trials are conducted in large numbers (n=100-300) of healthy volunteers. Due to the highly competitive nature of the biosimilars space and the potential for regulatory exclusivity for first movers, there is an urgent need for a cost-effective, global solution to enable timely recruitment of these large populations of healthy volunteers.

The most effective research efforts have the entire drug development program in mind when setting up the Phase I biosimilar program – especially when considering accelerated approaches, such as launching a Phase III program based on Phase I interim analysis.

To minimize the time and cost of recruiting and operating these trials, researchers should conduct a feasibility assessment to define their site identification strategy. This assessment will enable them to identify a list of sites that meet trial criteria, including expertise, interest, infrastructure, and access to patients. Then they can hone the list using a “site ranking algorithm” to target the smallest number of potential sites to deliver the required number of healthy volunteers, taking account of the volunteer population by site.

Ideal sites for Phase I biosimilars studies will have the following characteristics

  • Location close to a large population center, because typical biosimilar Phase I studies enroll 100-300 healthy volunteers.
  • Strong transportation network, because typical studies last six to eight months, requiring at least a dozen visits
  • Good medical infrastructure, including access to emergency facilities and 24-hour medical and nursing coverage since medical follow-up and laboratory access are required.
  • A regulatory environment that allows acceptance of Phase I data/interim safety data, offers rapid Institutional Review Board and Ethics Committee reviews, and a reasonable timeline for regulatory approval.
  • Experience in conducting Phase I trials, demonstrating commitment to subject safety, clinical quality and data integrity.
  • A limited number of competitive current Phase I trials.

It may seem like a simple process to narrow down this search, but researchers often find themselves having to choose between competing benefits and risks. For example, patient recruitment can be accelerated by choosing the countries or markets that have the greatest unmet need for the biosimilar – i.e., those that have only limited or no access to the innovator biologic. However the sites in these markets may have little experience running biosimilar clinical trials, and/or they may lack the basic infrastructure and talent pool to effectively manage these trials.

On the other hand, companies can accelerate speed-to-market by selecting markets in which regulatory agencies are willing to work with companies to bring biosimilars into market earlier, most often in markets where governments are incentivized to reduce healthcare costs. However, sites in these markets may be less interested in participating in biosimilars development, because it does not involve novel research and there will likely be more competition for patients.

To make the right decisions, sponsors should consider working with a provider that has expertise in the biosimilars space, and connections with a network of trial sites that have demonstrated the ability to conduct accelerated enrollment and oversight of biosimilars trials. The most suitable partners will have a global footprint, access to a large array of qualified investigators, and proactive approaches for recruiting patients or healthy volunteers for the trials required for registration.

Choosing the right partners, and developing a strategic plan with clear site goals and a robust feasibility process can accelerate the trial process and speed the biosimilar to market. Making such an upfront decision can deliver significant health and financial benefits for everyone involved.

Topics in this blog post: Biosimilars, Clinical Trials, Emerging Markets, Recruiting