Biosimilars

Bring your biosimilar to market faster.

Partner with us to develop biosimilar products more quickly and cost effectively – from clinical and operational planning to pipeline prioritization and feasibility analyses to full-service study execution.

Innovative approaches to improve biosimilar studies

IQVIA’s Biosimilars Center of Excellence (COE) partners with sponsors to optimize the velocity, integrity, and value of every biosimilars study using market intelligence, proven best practices, strategy and protocol development, trial operations, regulatory support, as well as medical and clinical expertise across therapeutic areas. Engage early with this COE on an operational blueprint, comparator sourcing, and feasibility analysis.

Gain instant access to regulatory insights and timely guidance from national authorities around the world. This intelligence helps customers avoid resource-intensive collection of regulatory information, reduce margin for error, and prepare for FDA and EMA reviews. Learn more.

The IQVIA Institute examines the current state of biosimilars market opportunities in different geographic regions and therapeutic areas. These reports assess factors impacting biosimilar uptake, including reimbursement and provider type. The IQVIA Institute also consolidates publicly available information on preclinical development and trial registries in a global biosimilars database. Learn more about the U.S. market outlook.

The biosimilars Center of Excellence has a 360-degree understanding of key trends, new compounds in the pipeline, the reference business outlook for biologics, and the patent expiry timetable. Our team applies insights about the state of the art in biosimilars clinical development to help sponsors assess their R&D assets and optimize biosimilar investments.

IQVIA network of partner sites benefit biosimilar sponsors in numerous ways. These sites are pre-qualified and have collaborated with strong operational efficiencies during previous trials, which enhances patient recruitment, speeds activation times, and improves data delivery. Learn more.

IQVIA’s specialists help sponsors find the most direct route from breakthrough science to new therapies. Collaborate with IQVIA clinical development, laboratory, medical, R&D, biostatistics, and other domain experts. Draw upon Oncology, GI, and CNS specialists for complex biosimilar development profiles. Learn more.

Leverage IQVIA’s management of clinical workloads and advanced analytics capabilities to assess recruitment, drop-out rates, visits, and other crucial patient data; compare site performance on sample and endpoint collection; and evaluate early safety data. Operational insights from these analyses can streamline study scale and timelines. Learn more.

Advise

  • Global Clinical and Regulatory Strategy
  • Regulatory Consultations with Health Agencies
  • Innovative Approaches to Clinical Development
  • Chemistry Manufacturing and Controls and Compliance
  • Feasibility and Therapeutic Strategy
  • Pipeline Selection and Prioritization

Develop

  • Experienced Biosimilar Operations Team
  • Phase I/III Accelerated Solution
  • Phase I Site Networks
  • Regulatory Agency Support
  • Multisource Comparator Access
  • Q2 Biomarker Development and Lab Services
  • Clinical Development Operating Model
  • Investigator and Patient Best Practices

Commercialize

  • Commercial Strategy and Integrated Launch Planning
  • Integrated Market Access
  • Medical Affairs
  • Medical Communications / Marketing
  • Commercial Infrastructure and Oversight
  • Payer Engagement Services
  • Performance Tracking
  • Pharmacovigilance / Risk Management

The power of IQVIA Connected Intelligence™

Tap into the power of the IQVIA Connected Intelligence™ to help achieve study outcomes and bring biosimilar drugs to market faster.

  • Analysis of multiple data sources to optimize biosimilar drug development.
  • Predictive modeling and data analytics to enhance country mix, select the best sites, and augment patient enrollment.
  • Proactive, independent feasibility analyses to inform strategy.
  • Transformative technology that hastens study timelines through real-time access to operation-critical information.

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