Accelerating Biosimilars Product Development Safely and Effectively
Many innovator biologics are approaching patent expiration, and the biosimilars, or “follow-on,” market is poised to experience substantial growth as biopharmaceutical companies prepare to quickly deliver less expensive versions of already-marketed biologics.
Although biologics are inherently highly complex, a biosimilar must be “highly similar” to its parent biologic and demonstrate similar clinical results. PPD offers a full range of consulting, regulatory, laboratory and clinical development services to support biosimilar product development.
We are experienced in developing customized development programs for a range of biosimilars aimed at supporting marketing authorization application in emerging and developed markets. PPD has supported the development of all top 10 selling biological products and has conducted studies on biologics involving more than 260,000 patients and 20,000 sites globally.
PPD offers a full range of cGMP and bioanalytical laboratory and clinical development services, which support a seamless approach to biosimilar drug development. This approach includes integrating the structural and functional comparability assessments with the clinical program and regulatory submission strategy in a step wise fashion, progressively reducing residual uncertainty and minimizing the clinical program needed to demonstrate similarity. Our expertise crosses multiple therapeutic areas, including oncology, rheumatoid arthritis and anemia associated with chronic kidney disease.
End-to-End Services in Biosimilar Development
We help keep your biosimilar product development program on track with:
- A seamless approach that includes structural and functional comparability of products, CMC support (cGMP and bioanalytical labs), preclinical development, pharmacokinetic/pharmacodynamic analysis, regulatory affairs, biostatistics clinical development programs and biosimilar trial conduct
- A cross-functional team of experts knowledgeable in meeting all product comparability requirements in both emerging and developed markets
- In-depth knowledge of the biosimilars regulatory landscape to ensure your product meets regulatory requirements around the globe
- A global biosimilar investigator network to address challenges in finding qualified investigators to conduct studies across a broad range of therapeutic specializations, allowing clients a more streamlined process for site recruitment and study start up
Shaping and Navigating the Global Regulatory Landscape
PPD remains in constant dialog with local health authorities, regulatory agencies, key opinion leaders and treatment specialists. We have a thorough understanding of current requirements, and we keep you fully aware of the evolving landscape to ensure your products remain in compliance from start to finish.
Comparability Assessments Tailored to Your Product
While regulatory guidelines evolve, one thing remains clear – comparability must be proven in regard to safety, purity and potency. We deliver strategic consultation and a customized program for your product, which may include:
- Structural and functional assessments to demonstrate analytical comparability
- Pharmacological studies to establish comparable potency and biological activity
- Toxicological studies
- Clinical trials designed to demonstrate comparability
Learn how PPD can deliver a customized strategy depending on your biosimilar and intended markets.