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)
| Biosimilar Name | Approval Date | Reference Product | Target |
|---|---|---|---|
| Hercessi (trastuzumab-strf) | April 2024 | Herceptin (trastuzumab) | Her2 (EGFR2) |
| Selarsdi (ustekinumab-aekn) | April 2024 | Stelara (ustekinumab) | IL-12 and IL-23 |
| Tyenne (tocilizumab-aazg) | March 2024 | Actemra (tocilizumab) | IL-6 receptor |
| Jubbonti and Wyost (denosumab-bbdz) | March 2024 | Prolia and Xgeva (denosumab) | RANKL |
| Simlandi (adalimumab-ryvk) | February 2024 | Humira (adalimumab) | TNFα |
| Avzivi (bevacizumab-tnjn) | December 2023 | Avastin (bevacizumab) | VEGF-A |
| Wezlana (ustekinumab-auub) | October 2023 | Stelara (ustekinumab) | IL-12 and IL-23 |
| Tofidence (tocilizumab-bavi) | September 2023 | Actemra (tocilizumab) | IL-6 receptor |
| Tyruko (natalizumab-sztn) | August 2023 | Tysabri (natalizumab) | α4-integrin |
| Yuflyma (adalimumab-aaty) | May 2023 | Humira (adalimumab) | TNFα |
| Idacio (adalimumab-aacf) | December 2022 | Humira (adalimumab) | TNFα |
| Vegzelma (bevacizumab-adcd) | September 2022 | Avastin (bevacizumab) | VEGF-A |
| Cimerli (ranibizumab-eqrn) | August 2022 | Lucentis (ranibizumab) | VEGF-A |
| Alymsys (bevacizumab-maly) | April 2022 | Avastin (bevacizumab) | VEGF-A |
| Yusimry (adalimumab-aqvh) | December 2021 | Humira (adalimumab) | TNFα |
| Byooviz (ranibizumab-nuna) | September 2021 | Lucentis (ranibizumab) | VEGF-A |
| Riabni (rituximab-arrx) | December 2020 | Rituxan (rituximab) | CD20 |
| Hulio (adalimumab-fkjp) | July 2020 | Humira (adalimumab) | TNFα |
| Avsola (infliximab-axxq) | December 2019 | Remicade (infliximab) | TNFα |
| Abrilada (adalimumab-afzb) | November 2019 | Humira (adalimumab) | TNFα |
| Hadlima (adalimumab-bwwd) | July 2019 | Humira (adalimumab) | TNFα |
| Ruxience (rituximab-pvvr) | July 2019 | Rituxan (rituximab) | CD20 |
| Zirabev (bevacizumab-bvzr) | June 2019 | Avastin (bevacizumab) | VEGF-A |
| Kanjinti (trastuzumab-anns) | June 2019 | Herceptin (trastuzumab) | Her2 (EGFR2) |
| Trazimera (trastuzumab-qyyp) | March 2019 | Herceptin (trastuzumab) | Her2 (EGFR2) |
| Ontruzant (trastuzumab-dttb) | January 2019 | Herceptin (trastuzumab) | Her2 (EGFR2) |
| Herzuma (trastuzumab-pkrb) | December 2018 | Herceptin (trastuzumab) | Her2 (EGFR2) |
| Truxima (rituximab-abbs) | November 2018 | Rituxan (rituximab) | CD20 |
| Hyrimoz (adalimumab-adaz) | October 2018 | Humira (adalimumab) | TNFα |
| Ixifi (infliximab-qbtx) | December 2017 | Remicade (infliximab) | TNFα |
| Ogivri (trastuzumab-dkst) | December 2017 | Herceptin (trastuzumab) | Her2 (EGFR2) |
| Mvasi (Bevacizumab-awwb) | September 2017 | Avastin (bevacizumab) | VEGF-A |
| Cyltezo (Adalimumab-adbm) | August 2017 | Humira (adalimumab) | TNFα |
| Renflexis (Infliximab-abda) | May 2017 | Remicade (infliximab) | TNFα |
| Amjevita (Adalimumab -atto) | September 2016 | Humira (adalimumab) | TNFα |
| Inflectra (Infliximab-dyyb) | April 2016 | Remicade (infliximab) | TNFα |
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 Oak Biosciences
Some Validated Biosimilar Antibodies from Oak Biosciences
| Molecule | Product (approved year) | Source | Target |
|---|---|---|---|
| Adalimumab | Humira (2002) | fully human IgG1 | TNFα |
| Bevacizumab | Avastin (2004) | Humanized IgG1 | VEGF |
| Trastuzumab | Herceptin (1998) | humanized IgG1 | Her2 |
| Rituximab | Rituxan (1997) | chimeric murine/human IgG | CD20 |
| Veltuzumab | / (2015) | humanized IgG1 | CD20 |
| Infliximab | Remicade (1998) | chimeric murine/human IgG | TNFα |
| Abciximab | ReoPro (1994) | chimeric human-murine Fab | integrin αIIbβ3 |
| Cetuximab | Erbitux (2004) | chimeric human/mouse IgG1 | EGFR |
| Pembrolizumab | Keytruda (2014) | humanized IgG4 S228P | PD-1 |
| Nivolumab | Opdivo (2014) | humanized IgG4 S228P | PD-1 |
| Atezolizumab | Tecentriq (2016) | humanized IgG1 | PD-L1 |
| Ipilimunab | Yervoy (2011) | humanized IgG1 | CTLA4 |
| Daclizumab | Zenapax (2011) | humanized IgG1 | CD25 |
| Pertuzumab | Perjeta (2012) | humanized IgG1 | Her2 |
| Sofituzumab | / | Humanized IgG1 from mouse | MUC16 |
| Ladiratuzumab | / | humanized IgG1 | LIV-1 |
| ranibizumab | Lucentis (2006) | humanized IgG1 | VEGF-A |
| tocilizumab | Actemra (2010) | humanizedIgG1 | IL-6 receptor |
| Ustekinumab | Stelara (2016) | human IgG1 | IL-12 and IL-23 |
| natalizumab | Tysabri (2004) | humanized IgG4 | α4-integrin |
| denosumab | Prolia and Xgeva (2010) | human IgG2 | RANKL |
| Urelumab | / | humanized IgG4 | CD137 receptor |
Process Overview
- Clients provide the biosimilar antibody name;
- Check our database to to get the identical sequence of the original therapeutic product, including both the variable region and Fc domain;
- Biosimilar antibody expression vector (both heavy chain and light chain) construction and sequence validation;
- Transient expression in either CHO cells or HEK293 cells;
- Affinity purification and polishing by size exclusion-high-performance liquid chromatography (if necessary).
Deliverables
- Purified biosimilar antibodies in carrier-free buffer or client chosen buffer.
- Certificate of Analysis (COA) data sheet.
Ordering Information
Biosimilar Antibody Production Services
| Catalog | Description | Unit | Price |
|---|---|---|---|
| 82186 | Biosimilar antibody production in CHO tranisent expression system | 1 Project | Contact Us |
| 82188 | Biosimilar antibody production in HEK293 tranisent expression system | 1 Project | Contact Us |
For complex projects, please fill the form for a customized quotation and proposal!