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biosimilar development

Biosimilars Drug Research and Development

PPD Biosimilars Program Brings Your Drug To Market 

PPD is at the forefront of biosimilar development and has the full expertise and dedicated team of professionals committed to support organizations of all sizes. Our experience spans a broad spectrum of therapeutic areas and services.

We supported development of all top 10 selling biological products and successfully delivered the first Monoclonal Antibody Biosimilar to the EU market.

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Biosimilar studies


Biosimilar-experienced sites around the world

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Patients enrolled

We Understand the Biosimilar Process

Biosimilars represent a viable way to fill expanding pipeline gaps but also expand access to life-changing and life-saving therapies for patients by providing less expensive versions of already-marketed biologics. We offer a full range of biosimilar drug development services, from cell line development and characterization to clinical development and market approval.

BIG: Biosimilar Intelligence Group

PPD has established a global Biosimilar Intelligence Group (BIG), including experts in biosimilars development within their area of expertise. PPD’s BIG members represent various specialties in the area of biosimilar development and work together to evaluate, design and execute biosimilar clinical development programs from beginning to the end. PPD clients engage our BIG members to provide insight into biosimilar protocol designs and study conduct to maximize investigator’s interest in biosimilar trials and optimize clinical trial enrollment.

Specialty Therapies and Biosimilars

Our biosimilar development services group ensures your program is fully integrated and streamlined in a way that results in maximum efficiencies and effectiveness. Our seamless development approach includes integrating structural and functional comparability assessments with the clinical program and regulatory submission strategy in a stepwise fashion to reduce residual uncertainty.

Biosimilar Approval Pathway Experience

Our experienced team can provide strategic guidance in all operational activities.

  • 20 years of biologics experience, generating and communicating evidence of effectiveness and efficient delivery
  • Global footprint with access to network of top performer countries/sites for biosimilar studies based on experience, regulatory landscape and site relationships
  • Activated and contracted with more than 2,200 sites across all 4 regions, from Phase I to Post-registration studies
  • Top performance: PPD site start-up team has a track record of delivering site activations for faster biosimilar studies