As patents for several key biopharmaceutical products have expired or are shortly due to expire, many companies are now developing biosimilars to these products. BioPharmaSpec provides a full range of biosimilar characterization and comparability services to support the development of your biosimilar.
The EMA guideline EMA/CHMP/BWP/247713/2012 “Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)” states that the biosimilar product should be characterized thoroughly and shown to be comparable to a reference medicinal product:
- The target amino acid sequence of the biosimilar should be confirmed and shown to be the same as the reference medicinal product.
- The N- and C-terminal amino acid sequences, free sulfhydral groups and disulfide bridges should be compared.
- Any modifications/truncations should be quantified.
- The presence and extent of post-translational modifications (e.g. glycosylation, oxidation, deamidation, truncation) should be appropriately characterized.
- If present, carbohydrate structures should be thoroughly compared, including the overall glycan profile, site- specific glycosylation patterns and also site occupancy.