Biosimilar Antibodies

• Our biosimilar antibodies are made using the identical sequence of the original therapeutic product, with no alteration or truncation, including variable region and Fc domain.
• Our proprietary recombinant antibody expression will scale to meet your growing needs with high yields and lot-to-lot consistency.
• Specifically detect biosimilar antibodies in bridging assays with anti-idiotype antibodies.

Biosimilars are biological products, such as antibodies and proteins, that are highly similar in structure, function, and efficacy to FDA-approved biopharmaceuticals (also called reference products). Biosimilar antibody development at Bio-Techne includes in silico design and reverse engineering to generate both light chain (lc) and heavy chain (hc) sequences for each antibody. After transfection of the dual expression vector, Bio-Techne’s biosimilar antibodies undergo rigorous application testing to ensure the final biosimilar product is suited for your research needs.

Biosimilar antibodies are utilized in bioequivalence studies to demonstrate similarity to the reference product, ensuring comparable efficacy and safety profiles for novel therapeutics. Important characteristics to compare to determine equivalency are kinetics, functionality, and surface charge characterization (e.g. capillary isoelectric focusing, cIEF).  Additionally, biosimilar antibodies can be used in therapeutic research to explore potential treatment options for “off-label” diseases.

Biosimilar antibodies are also commonly used in bridging assays, including anti-drug antibody (ADA) and pharmacokinetic (PK) assays. ADA assays utilize biosimilar antibodies to capture and detect anti-drug antibodies in patient samples and quantify the immune response. These assays help evaluate the immunogenicity of a biosimilar and, therefore, provide insight into safety and efficacy of potential therapeutics. PK assays are used to investigate a drug’s absorption, distribution, metabolism, and excretion. Understanding the PK profile helps establish appropriate drug dosing to ensure optimal therapeutic outcomes. Research grade biosimilar antibodies, paired with anti-idiotype antibodies, can serve as controls and calibration standards in PK assays.

Anti-idiotype antibodies are antibodies that target and bind to the antigen binding site, or complementarity determining region (CDR), of other antibodies. In relation to biosimilars, our anti-idiotype antibodies are designed to bind and detect specific biosimilar antibodies. For example, our anti-Rituximab Antibody will only bind to our Rituximab biosimilar antibody. Anti-idiotype antibodies are invaluable tools in the development and evaluation of antibody therapies, specifically for PK bridging assays (shown below) or as positive controls for ADA assays. Bio-Techne offers anti-idiotype antibodies that have been tested in-house to confirm specificity and functionality, ensuring they are reliable tools for assay development.

If you can’t find the anti-idiotype antibody that you need for your experiment, leverage the skill and expertise of our antibody development scientists by contacting our custom antibody services team.