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 NameApproval DateReference ProductTarget
Hercessi (trastuzumab-strf)April 2024Herceptin (trastuzumab)Her2 (EGFR2)
Selarsdi (ustekinumab-aekn)April 2024Stelara (ustekinumab)IL-12 and IL-23
Tyenne (tocilizumab-aazg)March 2024Actemra (tocilizumab)IL-6 receptor
Jubbonti and Wyost (denosumab-bbdz)March 2024Prolia and Xgeva (denosumab)RANKL
Simlandi (adalimumab-ryvk)February 2024Humira (adalimumab)TNFα
Avzivi (bevacizumab-tnjn)December 2023Avastin (bevacizumab)VEGF-A
Wezlana (ustekinumab-auub)October 2023Stelara (ustekinumab)IL-12 and IL-23
Tofidence (tocilizumab-bavi)September 2023Actemra (tocilizumab)IL-6 receptor
Tyruko (natalizumab-sztn)August 2023Tysabri (natalizumab)α4-integrin
Yuflyma (adalimumab-aaty)May 2023Humira (adalimumab)TNFα
Idacio (adalimumab-aacf)December 2022Humira (adalimumab)TNFα
Vegzelma (bevacizumab-adcd)September 2022Avastin (bevacizumab)VEGF-A
Cimerli (ranibizumab-eqrn)August 2022Lucentis (ranibizumab)VEGF-A
Alymsys (bevacizumab-maly)April 2022Avastin (bevacizumab)VEGF-A
Yusimry (adalimumab-aqvh)December 2021Humira (adalimumab)TNFα
Byooviz (ranibizumab-nuna)September 2021Lucentis (ranibizumab)VEGF-A
Riabni (rituximab-arrx)December 2020Rituxan (rituximab)CD20
Hulio (adalimumab-fkjp)July 2020Humira (adalimumab)TNFα
Avsola (infliximab-axxq)December 2019Remicade (infliximab)TNFα
Abrilada (adalimumab-afzb)November 2019Humira (adalimumab)TNFα
Hadlima (adalimumab-bwwd)July 2019Humira (adalimumab)TNFα
Ruxience (rituximab-pvvr)July 2019Rituxan (rituximab)CD20
Zirabev (bevacizumab-bvzr)June 2019Avastin (bevacizumab)VEGF-A
Kanjinti (trastuzumab-anns)June 2019Herceptin (trastuzumab)Her2 (EGFR2)
Trazimera (trastuzumab-qyyp)March 2019Herceptin (trastuzumab)Her2 (EGFR2)
Ontruzant (trastuzumab-dttb)January 2019Herceptin (trastuzumab)Her2 (EGFR2)
Herzuma (trastuzumab-pkrb)December 2018Herceptin (trastuzumab)Her2 (EGFR2)
Truxima (rituximab-abbs)November 2018Rituxan (rituximab)CD20
Hyrimoz (adalimumab-adaz)October  2018Humira (adalimumab)TNFα
Ixifi (infliximab-qbtx)December 2017Remicade (infliximab)TNFα
Ogivri (trastuzumab-dkst)December 2017Herceptin (trastuzumab)Her2 (EGFR2)
Mvasi (Bevacizumab-awwb)September 2017Avastin (bevacizumab)VEGF-A
Cyltezo (Adalimumab-adbm)August 2017Humira (adalimumab)TNFα
Renflexis (Infliximab-abda)May 2017Remicade (infliximab)TNFα
Amjevita (Adalimumab -atto)September 2016Humira (adalimumab)TNFα
Inflectra (Infliximab-dyyb)April 2016Remicade (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

MoleculeProduct (approved year)SourceTarget
AdalimumabHumira (2002)fully human IgG1TNFα
BevacizumabAvastin (2004)Humanized IgG1VEGF
TrastuzumabHerceptin (1998)humanized IgG1Her2
RituximabRituxan (1997)chimeric murine/human IgGCD20
Veltuzumab/ (2015)humanized IgG1CD20
InfliximabRemicade (1998)chimeric murine/human IgGTNFα
AbciximabReoPro (1994)chimeric human-murine Fabintegrin αIIbβ3
CetuximabErbitux (2004)chimeric human/mouse IgG1EGFR
PembrolizumabKeytruda (2014)humanized IgG4 S228PPD-1
NivolumabOpdivo (2014)humanized IgG4 S228PPD-1
AtezolizumabTecentriq (2016)humanized IgG1PD-L1
IpilimunabYervoy (2011)humanized IgG1CTLA4
DaclizumabZenapax (2011)humanized IgG1CD25
PertuzumabPerjeta (2012)humanized IgG1Her2
Sofituzumab/Humanized IgG1 from mouseMUC16
Ladiratuzumab/humanized IgG1LIV-1
ranibizumabLucentis (2006)humanized IgG1VEGF-A
tocilizumabActemra (2010)humanizedIgG1IL-6 receptor
UstekinumabStelara (2016)human IgG1IL-12 and IL-23
natalizumabTysabri (2004)humanized IgG4α4-integrin
denosumabProlia and Xgeva (2010)human IgG2RANKL
Urelumab/humanized IgG4CD137 receptor

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).
Oak Biosciences biosimilar antibody production flow chart
Oak Biosciences biosimilar antibody production flow chart


  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

82186Biosimilar antibody production in CHO tranisent expression system1 ProjectContact Us
82188Biosimilar antibody production in HEK293 tranisent expression system1 ProjectContact Us

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