Biosimilars or follow-on biologics cannot be considered true generics because while the manufacturing process produces micro-heterogeneity it is impossible to make identical copies of a biological molecule.

Biosimilars have been firmly established in Europe for a number of years, but there was no regulatory pathway in the US until the enactment of the Affordable Care Act (ACA) in 2010. This disparity led the EMA to establish specific guidelines, detailing requirements for different categories of biosimilars currently approved. These specific guidelines are valuable in the development of standards for biologics, since the complexity of structure and glycosylation differs greatly across the categories. Policies mirroring EMA guidelines are not yet issued by the FDA but are expected to be developed in due course.

Regardless of the target registration country for your biosimilar, it is important to establish comparability (EU) or similarity (US) between your biosimilar and its reference product. The burden of providing evidence for this biosimilarity starts with a detailed characterisation of the innovator, allowing the establishment of its critical quality attributes (CQAs) and then generating comparability datasets from multiple lots of the innovator (or reference) biologic.

Demonstrating physiochemical, structural and biological potency comparability will permit an abbreviated clinical phase for the biosimilar's development, thus reducing the time to market. In addition to proving comparability at a protein or glycoprotein level the biosimilar must also exhibit similarity in the impuritiy and stability  profile.

RSSL biopharmaceutical experts have a highly specialised understanding of protein structure, biochemistry and function. Our biosimilar characterisation services include:

Establishment of Innovator Quality attributes

Ongoing Characterisation of Innovator CQA

  • Multiple lots
  • Different shelf life
  • Different territories

Cell Line Selection and Expression Optimisation

  • Quality attribute monitoring to match innovator profile
  • Raw material testing
  • Functional and Potency Assays

Full Characterization of Biosimilar to ICH Q6B for Multiple Batches

  • Molecular weight – intact and reduced mass
  • Primary amino acid sequence - peptide mass (MS/MS)
  • Assessment of post-translational modifications
  • Glycosylation - population and site specific glycans
  • Aggregation
  • Higher order structure
  • Product related impurities
  • Biological activity/potency
  • Process related impurities
  • Stability

Formal Comparability

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