Biosimilar Development

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. GCR offers a full range of consulting, regulatory, laboratory and clinical development services to support biosimilar product development.

Biosimilar Development

We are experienced in developing customised development programs for a range of biosimilars aimed at supporting marketing authorisation application in emerging and developed markets.

Our laboratories offers a full range of GMP and bioanalytical lab 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 minimising 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 (GMP 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 specialisations, allowing clients a more streamlined process for site recruitment and study start up