Biosimilar Antibodies

A biosimilar antibody is a copy of a therapeutic antibody that has been approved for medical use. These biosimilar antibodies are highly similar in quality and efficacy to the original therapeutic antibodies. They provide an affordable alternative for researchers and clinicians. Biosimilar antibodies can be used for various research applications, including functional assays, flow cytometry, ELISA, immunohistochemistry, and pharmacokinetic assays. Additionally, the Food and Drug Administration (FDA) approves biosimilar products, providing the scientific and regulatory advice needed to bring safe and effective biosimilars to the market. This approval can improve access to care for patients by increasing the number of medication options and potentially lowering costs.

The FDA approves biosimilar antibodies and provides the scientific and regulatory advice needed to bring safe and effective biosimilar antibodies to market.

FDA-Approved Biosimilar Antibodies

Biosimilar Antibody Information from FDA (as of: 04/25/2024)

Research Use Only (RUO) biosimilar antibodies are valuable tools for biomedical research. These antibodies offer cost-effective alternatives for studying and characterizing specific disease targets in critical fields such as immuno-oncology, autoimmunity, and inflammatory disease research.

1. What Are Biosimilar Antibodies?

Biosimilar antibodies are recombinant antibodies that incorporate the same variable region sequence as therapeutic antibodies.

They are designed for research use only and are not intended for clinical applications.

Biosimilar antibodies are produced using the identical sequence of the original therapeutic product, including both the variable region and Fc domain.

2. Applications of RUO Biosimilar Antibodies:

Researchers use RUO biosimilar antibodies in various applications, including:

1) Flow Cytometry: To analyze cell surface markers.

2) ELISA (Enzyme-Linked Immunosorbent Assay): For detecting and quantifying specific proteins.

3) Immunohistochemistry (IHC): To visualize protein expression in tissue sections.

4) Pharmacokinetic (PK) Studies: To study drug distribution and elimination.

5) Functional Assays: To assess antibody activity.

6) Surface Plasmon Resonance (SPR): For real-time label-free protein binding analyses.

3. Advantages of RUO Biosimilar Antibodies:

1) Cost-Effective: RUO biosimilar antibodies provide an economical alternative for researchers.

2) Consistency: They offer lot-to-lot consistency, ensuring reliable results.

3) Critical Controls: Biosimilar antibodies can serve as essential controls to benchmark novel treatments.

4) Bridging Assays: Researchers can specifically detect biosimilar antibodies using anti-idiotype antibodies in bridging assays.

Remember that biosimilar antibodies are for research purposes only, and their use in clinical settings is not recommended.

Biosimilar Antibodies from Fusion Biolabs

Some Validated Biosimilar Antibodies from Fusion Biolabs

Process Overview

1. Clients provide the biosimilar antibody name;
2. Check our database to to get the identical sequence of the original therapeutic product, including both the variable region and Fc domain;
3. Biosimilar antibody expression vector (both heavy chain and light chain) construction and sequence validation;
4. Transient expression in either CHO cells or HEK293 cells;
5. Affinity purification and polishing by size exclusion-high-performance liquid chromatography (if necessary).

Deliverables

1. Purified biosimilar antibodies in carrier-free buffer or client chosen buffer.
2. Certificate of Analysis (COA) data sheet.

Ordering Information

Biosimilar Antibody Production Services

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