Successful characterization of biosimilars: determining biological activities using bioassays

Biosimilars are biological products that demonstrate their equivalence to an already approved innovator (reference) product with regard to quality, safety and efficacy. In the past two decades, biological products have unequivocally established their importance in the pharmaceutical industry. Industry watchdogs are predicting that by 2015, eight of the top 10 pharmaceutical products will be biological products. Most of the top ranking innovator products are coming off patent protection, triggering the biosimilar industry into full action mode.

Success of any biosimilar program is dependent on a scientifically sound characterization that provides a comprehensive understanding of the chemical, physical and biological characteristics of the proposed biosimilar product when compared to the reference product. For a majority of the top selling innovator products, a cell-based potency assay has been used for measuring biological activity. Therefore, a well developed cell based potency assay, comparable to that used by a reference product, is a critical component of a characterization package of biosimilar products. In addition, regulatory agents have been challenging the biosimilar industry to include additional characterization on biological activity of their products if multiple mechanisms of action have been established based on clinical results generated by innovator products. For example, Antibody Dependent Cell Cytotoxicity (ADCC) has now been considered to be a mechanism of action for both Enbrel and Humira, in addition to protection from TNF-alpha mediated cytotoxicity/ growth inhibition. In such a case, regulatory agents may request the manufacturer of biosimilars of these products to demonstrate comparability using both a proliferation assay as well as ADCC assays.

As a leader in the cGMP contract testing industry, Eurofins Lancaster Laboratories has extensive experience in developing cell based potency assays, working closely with clients within the biosimilar industry and developing cell based potency assays to support process development as well as GMP lot release and stability testing. Biosimilar products Eurofins Lancaster Laboratories has worked on include Erythopoietin (Epogen), Etanercept (Enbrel), Adalimumab (Humira), Rituximab (Rituxan), Filgrastim/Pegfi grastim (Neupogen/Neulasta) and Trastuzumab (Herceptin). For additional information contact Bio/Pharmaceutical Business Development at 717-656-2300.