The development of biosimilar drugs requires a bioanalytical lab with extensive experience, broad technical capabilities and a deep understanding of the regulatory pathway. The development needs for biosimilars are unique relative to other biopharmaceutical compounds:
- Biosimilars must demonstrate comparable results — safety, purity, potency, stability and immunogenicity — to the innovator product and across product lots
- Comparison experiments make development and validations more complex and extensive
- Assays developed for the innovator product may require adjustments and/or redevelopment and validation due to the physicochemical attributes and functional activity of the biosimilar
- Biologics, by nature, are more variable than small molecules, making the analytical methods subject to variation across instruments, critical reagents, operators and even day-to-day and lab-to-lab differences
- Manufacturing changes may alter the biologic, which may affect function of immunogenicity
- Biosimilar submissions may face a higher degree of regulatory scrutiny and require a laboratory with demonstrated experience in this regard
In addition to bioequivalence (BE) studies, anti-drug antibody (ADA) safety and efficacy testing are critical to the development of biosimilars in order to explain and justify changes from the innovator. Disease states can also affect PK and ADA assessments (even in Phase I studies). Manufacturing changes introduced between studies for scale-up or patent reasons can also have an effect on those assessments.
We recognize that competition in the biosimilar arena breeds extremely tight timelines and we work closely with clients to meet these needs.
In addition to our standard biologics capabilities, PPD® Laboratories immunochemistry department has unique resources to support biosimilar studies including capacity, throughput (through automated assays and data review) and regulatory experience.
PPD Laboratories’ bioanalytical lab has supported more than 17 biosimilar programs in support of U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) submissions. We have an excellent FDA audit record, including more than 70 inspections. In addition, PPD Laboratories is one of only a very few labs that has been audited for its work in support of biosimilar submissions.
Explore our experience: