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BioSimilars

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:

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.

 

Regulatory Guidelines

 

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:

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”.