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. In fact, the coming decade is forecast to be an inflection point for biosimilars, where their patient impact and market size will grow tremendously.
It’s a vast opportunity, but biosimilar development can be challenging to execute. Developers must reverse engineer complex large molecules, define critical quality attributes, and carefully analyze both reference material and biosimilars—all while managing the typical complexities of bioprocessing. Biosimilar organizations also operate with narrow margins, as they strive to undercut the name-brand therapy and competition from other biosimilar companies to provide the most affordable option possible to patients.
To succeed in this competitive landscape, every stage in the biosimilar development process needs to be optimized, documented, and scalable. Importantly, these approaches depend on quality of your biosimilar analysis capabilities. For this reason, many turn to biosimilar testing services from proven biosimilar CDMOs that understand the needs and nuances of this growing global market.
This is where Avomeen’s biosimilar services can elevate your biosimilar development.
Avomeen’s biologics team has the skillsets, know-how, instrumentation, and tenacity to help make your biosimilar program a commercial success, despite stiff competition. Our expert scientists are well versed in both biologic analysis and reverse engineering approaches and can help accelerate your program (or programs).
To gain US FDA approval, it must be demonstrated that there are no clinically meaningful differences in the safety, purity, and potency of the biosimilar drug when compared to the reference product. Avomeen 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 both the reference and proposed biosimilar products to demonstrate a high degree of similarity.
A deep understanding of biologic and biosimilar analysis methodologies required to show structural and functional similarity.
Expert guidance on the data and documentation needed to meet the regulatory requirements of each 351(k) application, the first time around.
Fast turnaround times for robust data collection and documentation married to excellent communication and teamwork.
Biosimilar Characterization Methods and Capabilities
The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was established to provide an abbreviated regulatory pathway for biological products that closely resemble an approved therapeutic. The goal of this biosimilar pathway is to demonstrate biosimilarity, rather than independently establish the safety and effectiveness of the new product.
To accommodate regulatory requirements put forward in the BPCI Act and FDA standards, Avomeen has assembled a complete suite of biosimilar testing services. With deep industry experience, our scientists can help select and build biosimilarity methods, based on the nature of the reference product, its structure, and heterogeneity. Working with your team, we can then perform vital biosimilar analyses and collect data central to your 351(k) application. We can help you both determine whether an interchangeable product designation is appropriate and satisfy the FDA’s additional requirements for interchangeable biological products.
Our Biosimilar Analysis Capabilities Include:
- 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
Adapting Our Biosimilar Services to Accommodate Your Team
Alongside our analytical capabilities and biosimilar characterization experience, Avomeen proudly maintains a reputation for effective collaboration with our many partners. With experience across the biopharma landscape, we can readily integrate with your team to ensure the most effective working relationship. Whether you lack the analytical skillset to prepare your 351(k) application or simply don’t have the bandwidth to execute your timeline, we’re here to help. Avomeen can support your biosimilar program with a fit-for-purpose strategy complemented by our vetted regulatory knowledge.