Medicine 6

We’ve contributed to the pivotal or supportive trials and key Biologic License Applications (BLA) support services that led to the regulatory approval of 16 biologic drugs.


Biosimilar development differs significantly from innovator and generic development with its own set of unique challenges. Most important among these is that commercial success depends on being among the first biosimilars to the market. At PRA we understand these challenges and have deep expertise in all aspects of biosimilar development.

PRA has supported biosimilar development for many years including some of the earliest biosimilars to receive global approval. In addition to design and execution of clinical trials, PRA also has deep biosimilar subject matter expertise in key functions such as drug development, clinical study design, therapeutic experts, clinical pharmacology, pharmacokinetics regulatory strategy, biostatistics, and regulatory CMC.

Our Biosimilar Team can provide the following support:

  • Designing and executing integrated global biosimilar development strategies including clinical and regulatory
  • Supporting scientific advice meetings with regulatory agencies
  • Designing Clinical trials including interchangeability studies
  • Guiding creation of the quality target product profile
  • Extrapolation of indications to cover all approved for the originator
  • Asset or Program Management

From functional analyses to marketing authorization, we support our partners throughout the development lifecycle. Our comprehensive services include consultation, program strategy, clinical study design and execution, regulatory strategy, submissions and meeting support, biostatistics, bioanalytical services, safety monitoring, and license application – all available around the globe.

Patients and Healthy Volunteers

Research Sites

Biosimilar Trials

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  • Gap analysis of [preliminary] comparative analytical similarity assessment (eg, structural and functional data)
  • Design and execution of global biosimilar clinical plans including protocol development
  • Clinical pharmacology expertise and support for pharmacokinetic analyses
  • Supplementing or synergizing with client resources as a joint development team to execute and oversee programs
  • Collaborating closely or overseeing directly internal PRA study teams to ensure on-time and high-quality outcomes
  • Regulatory strategy and meetings and submissions of all types

Expertise and Experience

We participated in the conduct of pivotal or supportive trials and/or key Biological License Application (BLA) support services. These trials led to US Food and Drug Administration (FDA) and/or international regulatory approval for numerous products across therapeutic areas, including support for some of the initial biosimilars to be approved globally. In addition, we provide non-clinical services for many biosimilars projects.

Some of the operations roles with biosimilar trial delivery experience at PRA include:

  • 20+ Project Directors
  • 60+ Project Managers
  • 150+ Clinical Team Managers
  • 350+ Clinical Research Associates
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Pharmacology, Immunogenicity and Comparative Clinical Studies

We have extensive experience in executing required pivotal studies, including:

  • Larger and more complex Phase I studies
  • Phase III efficacy and safety comparability studies
  • Pharmacovigilance activities (e.g. RMPs, PASS)

We understand there’s no room for error in data management, data quality or safety. It’s essential to gain first to market advantage post patent expiration of the originator product.

Our mission is to deliver successful biosimilars on time. We use a thoughtful, customized approach to building a full development program, informed by our knowledge and best practices gathered from successful trials.

Biosimilars serve a critical market demand to provide more affordable treatments to patient populations in need. We are committed to developing creative solutions to solve the unique challenges posed by biosimilar development.

Mark Lane, Executive Director, Center of Global Drug Development, PhD, MS

Ensuring high-quality data while meeting today’s complex regulatory landscape.

Stringent regulatory requirements guide the development of biosimilar medicines and ensure the highest standard of quality, non-clinical, and clinical comparability data. The type and extent of data needed varies depending on the complexity of the molecule, the availability of an accepted surrogate endpoint, and the seriousness of safety concerns for the reference product or substance class. We develop our biosimilars development programs on a case-by-case basis.

Accelerating patient recruitment to save you time and money.

Patient recruitment consumes approximately 30% of the clinical timeline and often leads to trial delays. In addition to the standard clinical trial recruitment challenges, biosimilar trials also face competition against new biological molecules for the same disease area, other biosimilars in development, changes in standard of care, and a lack of incentives for investigators and patients.

We facilitate better patient recruitment by investing in the education of both investigators and patients. Our educational materials highlight the potential value of biosimilars as affordable alternatives to specialty medications. We also leverage our in-house expertise to identify sites with the greatest unmet need for biosimilars as well as the greatest potential for recruitment.

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