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 as well as the pharmacokinetic (PK) and immunogenicity (ADA) requirements of biosimilars. 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, Pharmacokinetic, Immunogenicity 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products containing biotechnology-derived proteins as active substance: quality issues – EMA/CHMP/BWP/247713/2012 Draft Guidance: Revision 1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”.