Follow-on Biologics
Back to the Future with Biosimilars
“Follow-on Biologics” encompasses both Biosimilars and Biobetters. Biosimilars are essentially newly manufactured versions of formerly patent protected biologics that will be marketed by competing developers. These products are therapeutically similar and have properties similar to existing biologics; however, are not identical due to protein complexity. They are likely to provide a lower cost of therapy. Biobetters are products which may carry the same therapeutic indication and work on similar targets as those of previously approved novel biologic therapeutics. However, Biobetters are differentiated by unique characteristics which convey superior clinical efficacy. This may be through attributes such as reduced dose, extended half-life, convenient dosage formulation and increased safety. Since Biobetters have mutations or other modifications, they are new compositions of matter, they require new clinical trials and are usually patent protected.
A key attribute for Biosimilars to be competitive will be lower manufacturing cost. BioAtla’s Powerful Expression Optimization for Biosimilars will enable low cost efficient production.
Complimentary to BioAtla’s proprietary CIAO!™ platform for simultaneous integrated selection and evolution of protein expression and performance to address substantial downstream costs and challenges of manufacturing beginning from the discovery of your drug.
BioAtla’s Biosimilar technology platform is based on the generation of a library of constant regions via codon mutagenesis for mammalian cell expression. Each new variant is screened as a full-length antibody expressed in mammalian cells (cost-effective media). Codon changes are then selected that allow increased expression, are combined and screened in mammalian cells for expression improvement. This system provides an opportunity for fine structure control for Biosilimars.
BENEFITS:
Begin managing downstream drug risk and cost from very early in the discovery and optimization process
Choose best candidate(s) early for downstream activities