Rely on the combined power of BioAgilytix’s veteran scientists, advanced platforms, and validated techniques to quickly progress the development of your promising biosimilars. Our scientists have experience supporting biosimilar studies with a number of assays for generics, including ligand binding assays, characterization, and stability testing on multiple platforms.
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A biosimilar is a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. Biosimilars are not to be confused with generic chemical medicines, which use identical active ingredients. It is critical to demonstrate the comparability of a biosimilar to its originator product not only to ensure safety and efficacy but also to allow for drug substitution and exchangeability.
The Biosimilars Council reports that by 2020, brand biologic medicines worth an estimated $81 billion in global annual sales will lose their patents. This provides a significant opportunity for the development of lower cost biosimilar alternatives, and the biosimilars market is expected to expand more than 20-fold in the next 5 years.
2013 Cai, Wake, Gouty paper
For more information on why it is critical to establish analytical and bioanalytical equivalency between biosimilars and originators – and the unique challenges this presents.
The rise of biosimilars brings with it the promise of broader patient access to important medicines for serious diseases. BioAgilytix is committed to supporting this area of innovation by bringing together the best scientists, technologies, and processes needed to develop and deliver reliable, high-quality biosimilars for a wide range of disease states.
Our scientists have experience supporting biosimilar studies with ligand binding assays, characterization, and stability testing on multiple platforms. We also possess robust expertise in analyzing samples from rodents, humans, and non-human primates under non-GLP, GLP, and in performing analyses under GMP regulations.
BioAgilytix is highly knowledgeable in the sensitivities of biologics development, and understands the challenges that biosimilar developers face. We have leading experience using the following platforms from our extensive technology suite to conduct immunogenicity and PK studies, biomarker studies, cell-based assays, ADA analyis, and NAb assays supporting biosimilars development.
ELISA
MSD-ECL
Gyrolab
ProteinSimple Ella
Biacore
Learn more about the most recent best practices for biosimilar assessment with this article from The American Association of Pharmaceutical Scientists (AAPS) biosimilar focus group.
The surge of upcoming patent expiries has driven demand for biosimilars – but without access to the originator’s molecular clone and cell bank, the exact fermentation and purification process, or the active drug substance, mimicking the performance of the branded original is extremely complex. Averaging over 15 years of bench experience, our veteran team of BPMs have world-leading expertise in biosimilars development, and will apply that knowledge to optimally support your project. We are able to offer services under GLP, GMP, and GCP to meet your distinct regulatory requirements.
The rise of biosimilars brings with it the promise of broader patient access to important medicines for serious diseases. BioAgilytix is committed to supporting this area of innovation by bringing together the best science, technologies, and processes needed to develop and deliver reliable, high-quality biosimilars for a wide range of disease states. Let our specialized scientists help you identify the optimal method and platform for your pharmacokinetic assay needs today.
Our Biosimilars-Related Services Include:
Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.
Gouty D, Cai CC, Cai XY, Kasinath A, Kumar V, Alvandkouhi S, Yang J, Pederson S, Babbitt B, Peritt D, Rudy A, Koppenburg V, Dasilva A, Ullmann M, Liu S, Satterwhite C. AAPS J. 2017 Dec 28;20(1):25. doi: 10.1208/s12248-017-0181-6.
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Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
Mansouri S, Zemo J, Alligood K. International Journal of Pharmacokinetics 2017 Jan; DOI 10.4155/ipk-2016-0024.
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Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.
Cai XY, Wake A, Gouty D. Bioanalysis. 2013 Mar; 5(5):517-20. doi: 10.4155/bio.13.1.
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Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.
Cai XY, Gouty D, Baughman S, Ramakrishnan M, Cullen C. Bioanalysis. 2011 Mar; 3(5):535-40. doi: 10.4155/bio.11.24. Review.
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See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.
Learn how we will translate our experience working with over 500 biomarkers in singleplex and multiplex formats to your project’s success.
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