BioOutsource is the industry leading expert in the biological analysis of biosimilar monoclonal antibodies. We have created a niche within the industry, dedicating ourselves to the biological evaluation of therapeutic antibodies, offering a comprehensive range of off-the-shelf biosimilar testing methodologies to support comparability, stability & lot release testing. With years of experience in the performance of cell based bioassays and variety of binding assays, coupled with off-the-shelf methods, we provide comprehensive expertise to reduce the both the time and cost of your biosimilar development programmes.
BioOutsource has recognised the need of manufacturers and has implemented a comprehensive program of assay development to fulfill an unmet market, providing unrivalled experience with a suite of off-the-shelf assay packages to complete a comparability study for the biological characterisation of a range of biosimilar molecules:
- Herceptin (trastuzumab) biosimilar testing
- Rituxan/Mabthera (rituximab) biosimilar testing
- Humira (adalimumab) biosimilar testing
- Enbrel (etanercept) biosimilar testing
- Remicade (infliximab) biosimilar testing
- Avastin (bevacizumab) biosimilar testing
In addition to our assays for comparability, we offer a wide range of services to support biosimilar development, including biosafety testing, lot release and stability and development of custom Phase III Host Cell Protein assays.
A BioSimilar is defined by the World Health Organisation as a “biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product”. Both the EMA and FDA have issued a range of guidelines detailing the requirements for biosimilar molecules:
- Similar biological medicinal products – CHMP/437/04
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues – EMEA/CHMP/BMWP/42832/2005
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues – EMEA/CHMP/BWP/49348/2005
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues – EMA/CHMP/BWP/247713/2012 Draft Guidance: Revision 1
- Guideline: Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues – EMA/CHMP/BMWP/403543/2010
- Comparability of biotechnology-derived medicinal products after a change in the manufacturing process – non-clinical and clinical issues – EMEA/CHMP/BMWP/101695/2006
- Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, FDA Draft Guidance, 2012
- Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, FDA Draft Guidance, 2012
- Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the of the Biologics Price Competition and Innovation Act of 2009
The current guidelines for biosimilars allow a reduced drug development programme, making entry to the market much faster for biosimilar manufacturers. Although the pathway to licensure for biosimilar monoclonal antibodies is reduced when compared to that of a new product, these cannot be considered identical to the innovator product and a number of assessments are required to demonstrate comparability. Comparability is defined as “a head-to-head comparison of a biosimilar product with a licensed originator product with the goal to establish similarity in quality, safety, and efficacy. Products should be compared in the same study using the same procedures”.