Biosimilars have emerged as one of the fastest-growing development opportunities in the biopharmaceutical sector. The European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and many other jurisdictions from various regions and countries have published and are continuously revising their guidances.

With extensive biological and biosimilar experience, Covance has been helping biosimilar clients with projects corresponding to a wide range of biologics, including most of the top 30 selling biologics.

Covance has conducted a wide variety of development activities for biosimilar clients. Ask us how we can help you in the following areas:

• Protein chemistry and structural characterization
• Bioassays
• cGMP stability and release
• Immunochemistry/PK-PD studies
• Toxicology studies
• Discovery models
• Clinical studies
• Regulatory consulting
• Commercialization