To succeed in the competitive, growing biologics market, each stage in the process of biosimilar development must be optimized, documented and scalable, all which depend upon the quality of your biosimilar analysis capabilities.

Leading biopharmaceutical organizations rely on biosimilar testing services from Element, a proven biosimilar CDMO, leveraging our unparalleled understanding of the needs and nuances of this growing global market to bring the safest and most efficacious biosimilar therapies to patients. With patient impact and market size projected to grow significantly, the coming decade is forecasted to be an inflection point for biosimilars.

To make the most of this vast opportunity, biosimilar developers face a myriad of challenges including reverse engineering complex large molecules, defining critical quality attributes, and carefully analyzing both reference material and biosimilars. Additionally, organizations embarking on the 351(k) application and regulatory pathway for biosimilar approval must navigate the typical complexities of bioprocessing as they work to achieve their mission of providing the most affordable, safe and efficacious and large molecule therapies to patients, undercutting name-brand therapies and competitive biosimilars.

Comprehensive biosimilar services and capabilities

  • Molecular identification
  • Amino acid sequence analysis
  • Purity assessments and impurity identification
  • Bioactivity and potency assays
  • Receptor binding and immunochemical property assays
  • Cell-based bioassay development and validation
  • Bridging studies
  • Structural analysis
  • Physicochemical properties assessments
  • Stability testing and forced degradation studies
  • Critical quality attribute (QCA) determination
  • DMPK/ADME analysis
  • Interchangeable biological product testing
  • Expression system review and selection
  • Manufacturing process review

Industry-leading support for the FDA 351(k) application and regulatory pathway

Despite stiff competition and well-understood analytical challenges, Element’s biologics team has the know-how, skillset, instrumentation and tenacity to support the commercial success of your biosimilar program. Detailed analytical characterization of the reference biologic and proposed biosimilar product is necessary to demonstrate the high degree of similarity required to meet 351(k) regulatory pathway requirements. To obtain approval from the FDA, 351(k) applications must establish there are no clinically meaningful differences in the safety, purity and potency of the biosimilar drug when compared to the reference product.

Furthermore, our comprehensive suite of biosimilar testing services, in addition to our thorough understanding of the regulatory landscape, can help you determine whether an interchangeable product designation is appropriate, per the FDA’s additional requirements for interchangeable biological products. Partner with Element and employ our biologic analysis, reverse engineering and regulatory expertise to accelerate your biosimilar program(s).

The Element advantage

With an ever-deepening bench of scientific and industry experience, Element’s scientists can help select and build biosimilarity methods based on the nature of the reference product, its heterogeneity and structure. Realize the full potential of your biosimilar program with a fit-for-purpose strategy complemented by our analytical capabilities, vetted regulatory knowledge and biosimilar characterization experience.

For more information about Element’s biosimilar characterization, testing and development services, or to request a quote, contact us today.

Our team of over 6,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.