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. As the biologics market continues to mature, more and more biologics will lose exclusivity, including a cadre of blockbusters that have generated billions in revenue worldwide. As these patents expire, biosimilar development efforts will continue to expand. 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 (CQAs), 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. Consequently, many turn to biosimilar testing services from proven biosimilar CDMOs that understand the needs and nuances of this growing global market.
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
Element’s biosimilar services can elevate your biosimilar development. 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. Our expert scientists are well versed in both biologic analysis and reverse engineering approaches and can help accelerate your program (or programs). Element understands the 351(k) application and approval pathway inside-and-out. Our expertise speaks directly to the foundation of the 351(k) application, which requires detailed analytical characterization of the reference biologic and proposed biosimilar product to demonstrate the high degree of similarity required to meet 351(k) regulatory pathway requirements. To obtain approval from the US Food and Drug Administration (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.
A deep understanding of biologic and biosimilar analysis methodologies required to show structural and functional similarity underpins our biosimilar service offerings. Our comprehensive suite of biosimilar testing services have been built upon a strong foundation of quality and efficiency, enabling fast turnaround times for robust data collection and documentation. Element’s consultative experts also have a deep understanding of the regulatory landscape, providing guidance on the data and documentation needed to meet the regulatory requirements of each 351(k) application, the first time around. We can also 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.
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