Biologics are critical components in the treatment of patients with cancer. Biosimilars - biologics that are highly similar to approved biologics - offer a potential opportunity to increase access to biologics by stimulating price competition and may lower healthcare costs. The active substance of a biosimilar and the original (approved medicine) are essentially the same biological substance, though there may be minor differences due to their complex nature and the production methods.
A consequence of the astronomical commercial value of mAbs associated with the patent expiry date (or estimated expiry date) is their attractiveness as candidates for biosimilar drugs.
An appropriate definition of biosimilars includes the following:
Biosimilars are more complex than small-molecule drugs and generics. Biological medicines (Biologics) are large, complex molecules produced from living organisms that are often difficult to characterize and therefore difficult to copy. Generic medicines (Generics) usually consist of small, identical molecules that are chemically synthesized. It is important to understand several key differences between biologics and small-molecule drugs. In addition, the manufacturing process for biologics is more complex than for small-molecule drugs, which requires multiple steps for cloning; selecting, maintaining, and expanding the cell line; and isolating, purifying, and characterizing the product (Fig. 1). Small-molecule drugs are synthesized through a series of predictable chemical reactions that can be reliably reproduced to yield identical copies.
Figure 1. Biologic manufacturing includes multiple steps that may vary between manufacturers, potentially leading to differences between a biosimilar and its reference product that cannot be fully characterized with available analytical methods. In contrast, small-molecule drugs are manufactured through chemical reactions that can be reliably reproduced to make identical copies (generics) that can be fully characterized.
Designed to be highly similar to originator biologic products, biosimilars represent an opportunity to increase access and reduce costs for patients and healthcare systems. Biosimilars of monoclonal need to demonstrate similar but not identical quality of nonclinical and clinical attributes. Not all data of the originator product need to be recapitulated, as large numbers of patient-years of exposure data are already available. A well-designed development program establishes biosimilarity based on structural, functional, preclinical, and clinical evaluation. A systematic approach for characterization of structural and functional similarity of a biosimilar molecule to the originator molecule provides specifications to guide the development of biosimilars. Biosimilar endpoints are defined for each tier of characterization, and evaluation of successive tiers addresses additional relevance of biosimilarity. Thus, biosimilar development is largely based on the safety profiles of the originator product. The biosimilarity analysis of biosimilars development is described as a five-step process:
Unlike the development of novel biologics, biosimilar data focus heavily on the molecular characterization of the mAb with randomised clinical studies confirming that any differences in physico-chemical or biological characterization compared with the reference mAb do not affect efficacy or safety (Figure 2). The challenge of biosimilar development requires intricate reverse engineering, as biologic drugs exhibit great molecular complexity and are sensitive to variations in manufacturing and handling.
Figure 2 Comparability and biosimilarity design of a biosimilar
Common monoclonal antibody biosimilars are listed below, along with the corresponding research-use-only products provided by Creative Biolabs:
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Canakinumab | IL1B | Anti-Human IL1Beta Recombinant Antibody (Canakinumab) | TAB-021 | Canakinumab Overview |
Cantuzumab Mertansine | MUC1 | Humanized Anti-MUC1 Recombinant Antibody (clone Cantuzumab) | TAB-166 | Cantuzumab Mertansine Overview |
Carlumab | CCL2 | Anti-Human MCP-1 Recombinant Antibody (Carlumab) | TAB-117 | Carlumab Overview |
Cetuximab | EGFR | Anti-Human EGFR Recombinant Antibody (Cetuximab) | TAB-003 | Cetuximab Overview |
Citatuzumab Bogatox | EPCAM | Anti-Human EpCAM Recombinant Antibody Fab Fragment, 17-1A (Citatuzumab Bogatox) | TAB-112-F(E) | Citatuzumab Bogatox Overview |
Cixutumumab | IGF1R | Anti-Human IGF1 Receptor Recombinant Antibody (Cixutumumab) | TAB-078 | Cixutumumab Overview |
Clenoliximab | CD4 | Anti-CD4 Recombinant Antibody (Clenoliximab) | TAB-732 | Clenoliximab Overview |
Codrituzumab | GPC3 | Anti-Human GPC3 Recombinant Antibody (Codrituzumab) | TAB-H14 | Codrituzumab Overview |
Concizumab | TFPI | Anti-TFPI Recombinant Antibody (Concizumab) | TAB-734 | Concizumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Daclizumab | IL2RA | Anti-Human CD25 Recombinant Antibody (Daclizumab) | TAB-023 | Daclizumab Overview |
Detumomab | B-cell Lymphomas | Anti-B Cell Lymphomas Recombinant Antibody (Detumomab) | TAB-737 | Detumomab Overview |
Dusigitumab | IGF2 | Anti-IGF2 Recombinant Antibody (Dusigitumab) | TAB-740 | Dusigitumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Edrecolomab | EpCAM | Anti-Human EpCAM/17-1A Recombinant Antibody (Edrecolomab) | TAB-701 | Edrecolomab Overview |
Elotuzumab | SLAMF7 | Anti-SLAMF7 Recombinant Antibody (Elotuzumab) | TAB-743 | Elotuzumab Overview |
Epitumomab | MS4A1 | Anti-Human MS4A1 Recombinant Antibody (Epitumomab) | TAB-H27 | Epitumomab Overview> |
Ertumaxomab | CD3E | Anti-Human CD3E Recombinant Antibody (Ertumaxomab) | TAB-H28 | Ertumaxomab Overview |
Etrolizumab | ITGA4 | Anti-Human Integrin alpha 4 beta 7 Recombinant Antibody (Etrolizumab) | TAB-135 | Etrolizumab Overview |
Exbivirumab | HBV | Anti-HBV Recombinant Antibody (Exbivirumab) | TAB-746 | Exbivirumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Fanolesomab | CD15 | Anti-Human CD15 Recombinant Antibody (Fanolesomab) | TAB-H32 | Fanolesomab Overview |
Faralimomab | IFNA1 | Anti-IFNA1 Recombinant Antibody (Faralimomab) | TAB-747 | Faralimomab Overview |
Figitumumab | IGF1R | Anti-Human IGF1 Receptor Recombinant Antibody (Figitumumab) | TAB-232 | Figitumumab Overview |
Firivumab | IAV HA | Anti-IAV HA Recombinant Antibody (Firivumab) | TAB-H33 | |
Flanvotumab | TYRP1 | Anti-Human TYRP1 Recombinant Antibody (Flanvotumab) | TAB-130 | Flanvotumab Overview |
Fletikumab | IL20 | Anti-Human IL20 Recombinant Antibody (Fletikumab) | TAB-H34 | Fletikumab Overview |
Fontolizumab | IFNG | Anti-Human IFNG Recombinant Antibody (Fontolizumab) | TAB-041 | Fontolizumab Overview |
Futuximab/Zatuximab | EGFR | Anti-EGFR/HER1 Recombinant Antibody (Futuximab/Zatuximab) | TAB-750 | Futuximab/Zatuximab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Galiximab | CD80 | Anti-Human CD80 Recombinant Antibody (Galiximab) | TAB-215 | Galiximab Overview |
Gemtuzumab Ozogamicin | CD33 | Anti-Human CD33 Recombinant Antibody (Gemtuzumab Ozogamicin) | TAB-H37 | Gemtuzumab Ozogamicin Overview |
Girentuximab | CA9 | Anti-CAIX/CA9 Recombinant Antibody (Girentuximab) | TAB-707 | Girentuximab Overview |
Glembatumumab | GPNMB | Afuco™ Anti-GPNMB ADCC Recombinant Antibody (Glembatumumab), ADCC Enhanced | AFC-TAB-751 | Glembatumumab Overview |
Gomiliximab | FCER2 | Anti-Human CD23 Recombinant Antibody (Gomiliximab) | TAB-231 | Gomiliximab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Ibritumomab | MS4A1 | Anti-Human CD20 Recombinant Antibody (Ibritumomab) | TAB-001 | Ibritumomab Tiuxetan Overview |
Ibritumomab Tiuxetan | MS4A1 | Anti-Human MS4A1 Recombinant Antibody (Ibritumomab) | TAB-H39 | Ibritumomab Tiuxetan Overview |
Imgatuzumab | EGFR | Anti-EGFR Recombinant Antibody (Imgatuzumab) | TAB-753 | Imgatuzumab Overview |
Inclacumab | SELP | Anti-Human selectin P Recombinant Antibody (Inclacumab) | TAB-246 | Inclacumab Overview |
Infliximab | TNF | Anti-Human TNF Recombinant Antibody (Infliximab) | TAB-006 | Infliximab Overview |
Inotuzumab Ozogamicin | CD22 | Humanized Anti-CD22 Recombinant Antibody (clone Inotuzumab) | TAB-198 | Inotuzumab Ozogamicin Overview |
Iratumumab | TNFRSF8 | Anti-Human CD30 Recombinant Antibody (Iratumumab) | TAB-144 | Iratumumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Lampalizumab | CFD | Anti-CFD Recombinant Antibody (Lampalizumab) | TAB-754 | Lampalizumab Overview |
Lilotomab | CD37 | Anti-Human CD37 Recombinant Antibody (Lilotomab) | TAB-467CQ | |
Lodelcizumab | PCSK9 | Anti-PCSK9 Recombinant Antibody (Lodelcizumab) | TAB-758 | |
Lorvotuzumab Mertansine | NCAM1 | Humanized Anti-NCAM1 Recombinant Antibody (clone Lorvotuzumab) | TAB-188 | Lorvotuzumab Mertansine Overview |
Lucatumumab | CD40 | Anti-CD40 Recombinant Antibody (Lucatumumab) | TAB-759 | Lucatumumab Overview |
Lumiliximab | CD23 | Anti-CD23 Recombinant Antibody Lumiliximab(Lumiliximab) | TAB-760 | Lumiliximab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Mapatumumab | TNFRSF10A | Anti-Human TNFRSF10A Recombinant Antibody (Mapatumumab) | TAB-H48 | Mapatumumab Overview |
Timigutuzumab | ERBB2 | Anti-Human ERBB2 Recombinant Antibody (Timigutuzumab | TAB-468CQ | Timigutuzumab Overview |
Margetuximab | ERBB2 | Anti-ERBB2 Recombinant Antibody (Margetuximab) | TAB-761 | Margetuximab Overview |
Matuzumab | EGFR | Anti-Human EGFR Recombinant Antibody (Matuzumab) | TAB-165 | Matuzumab Overview |
Minretumomab | TAG72 | Anti-Human TAG-72 Recombinant Antibody (Minretumomab) | TAB-249 | Minretumomab Overview |
Modotuximab | EGFR | Anti-Human EGFR Recombinant Antibody (Modotuximab) | TAB-H49 | Modotuximab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Narnatumab | MST1R | Anti-Human RON Recombinant Antibody (Narnatumab) | TAB-184 | |
Nebacumab | Endotoxin | Anti-Endotoxin Recombinant Antibody (Nebacumab) | TAB-767 | Nebacumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Olaratumab | PDGFRA | Anti-Human PDGF-R alpha Recombinant Antibody (Olaratumab) | TAB-192 | Olaratumab Overview |
Olokizumab | IL6 | Anti-Human IL-6 Recombinant Antibody (Olokizumab) | TAB-253 | Olokizumab Overview |
Omalizumab | IGHE | Anti-Human IGHE Recombinant Antibody (Omalizumab) | TAB-007 | Omalizumab Overview |
Ontuxizumab | CD248 | Anti-CD248 Recombinant Antibody (Ontuxizumab) | TAB-773 | Ontuxizumab Overview |
Otlertuzumab | CD37 | Anti-Human CD37 Recombinant Antibody (Otlertuzumab) | TAB-904 | Otlertuzumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Pagibaximab | S. epidermidis LTA | Anti-S. Epidermidis LTA Recombinant Antibody (Pagibaximab) | TAB-H53 | Pagibaximab Overview |
Pemtumomab | MUC1 | Anti-Human MUC1 Recombinant Antibody (Pemtumomab) | TAB-H56 | Pemtumomab Overview |
Perakizumab | IL17A | Anti-Human IL17A Recombinant Antibody (Perakizumab) | TAB-H57 | Perakizumab Overview |
Pexelizumab | C5 | Anti-Human C5 Recombinant Antibody (Pexelizumab) | TAB-901 | Pexelizumab Overview |
Pinatuzumab Vedotin | CD22 | Humanized Anti-CD22 Recombinant Antibody (clone Pinatuzumab) | TAB-899 | Pinatuzumab Vedotin Overview |
Plozalizumab | CCR2 | Anti-Human CCR2 Recombinant Antibody (Plozalizumab) | TAB-444CQ | Plozalizumab Overview |
Ponezumab | APP | Anti-Human Abeta Recombinant Antibody (Ponezumab) | TAB-227 | Ponezumab Overview |
Pritoxaximab | E. coli Stx1B | Anti-Shiga Toxin 1 B Subunit Recombinant Antibody (Pritoxaximab) | TAB-896 | Pritoxaximab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Racotumomab | NGCGM3 | Anti-Human NGcGM3 Recombinant Antibody (Racotumomab) | TAB-H58 | Racotumomab Overview |
Radretumab | FN1 | Anti-Human Fibronectin Extra Domain-B Recombinant Antibody (Radretumab) | TAB-193 | Radretumab Overview |
Raxibacumab | B. anthracis PA | Anti-B. Anthracis Anthrax Protective Antigen (Raxibacumab) | TAB-224 | Raxibacumab Overview |
Refanezumab | MAG | Anti-Human MAG Recombinant Antibody (Refanezumab) | TAB-447CQ | Refanezumab Overview |
Regavirumab | HCMV | Anti-Human Cytomegalovirus Glycoprotein B Recombinant Antibody (Regavirumab) | TAB-894 | Regavirumab Overview |
Rituximab | MS4A1 | Anti-Human CD20 Recombinant Antibody (Rituximab) | TAB-016 | Rituximab Overview |
Rivabazumab | PcrV | Anti-Pseudomonas Aeruginosa pcrV Recombinant Antibody Fab Fragment (Rivabazumab) | TAB-472CQ | Rivabazumab Overview |
Rosmantuzumab | RSPO3 | Anti-Human RSPO3 Recombinant Antibody (Rosmantuzumab) | TAB-449CQ | Rosmantuzumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Ustekinumab | IL12+IL23 | Anti-Human IL12+IL23 Recombinant Antibody (Ustekinumab) | TAB-063 | Ustekinumab Overview |
INN | Target | Product Name | Product CAT | Overview |
---|---|---|---|---|
Zanolimumab | CD4 | Anti-Human CD4 Recombinant Antibody (Zanolimumab) | TAB-039 | Zanolimumab Overview |
Zolimomab | CD5 | Mouse Anti-CD5 Recombinant Antibody (clone Zolimomab) | TAB-884 | Zolimomab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
AOC3 | Timolumab | Anti-Human AOC3 Recombinant Antibody (Timolumab) | TAB-455CQ | Timolumab Overview |
AOC3 | Vapaliximab | Anti-Human AOC3 Recombinant Antibody (Vapaliximab) | TAB-261 | |
APP | Ponezumab | Anti-Human Abeta Recombinant Antibody (Ponezumab) | TAB-227 | Ponezumab Overview |
APP | Solanezumab | Anti-Human Abeta Recombinant Antibody (Solanezumab) | TAB-228 | Solanezumab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
B. anthracis PA | Raxibacumab | Anti-B. Anthracis Anthrax Protective Antigen (Raxibacumab) | TAB-224 | Raxibacumab Overview |
B-cell Lymphomas | Detumomab | Anti-B Cell Lymphomas Recombinant Antibody (Detumomab) | TAB-737 | Detumomab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
FCER2 | Gomiliximab | Anti-Human CD23 Recombinant Antibody (Gomiliximab) | TAB-231 | Gomiliximab Overview |
FN1 | Radretumab | Anti-Human Fibronectin Extra Domain-B Recombinant Antibody (Radretumab) | TAB-193 | Radretumab Overview |
Frizzled Receptor | Vantictumab | Anti-Human Frizzled receptor Recombinant Antibody (Vantictumab) | TAB-880 | Vantictumab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
GPC3 | Codrituzumab | Anti-Human GPC3 Recombinant Antibody (Codrituzumab) | TAB-H14 | Codrituzumab Overview |
GPNMB | Glembatumumab | Afuco™ Anti-GPNMB ADCC Recombinant Antibody (Glembatumumab), ADCC Enhanced | AFC-TAB-751 | Glembatumumab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
HBV | Exbivirumab | Anti-HBV Recombinant Antibody (Exbivirumab) | TAB-746 | Exbivirumab Overview |
HCMV | Regavirumab | Anti-Human Cytomegalovirus Glycoprotein B Recombinant Antibody (Regavirumab) | TAB-894 | Regavirumab Overview |
HLA-DRB1 | Apolizumab | Anti-Human HLA DR beta Recombinant Antibody (Apolizumab) | TAB-150 | Apolizumab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
LOXL2 | Simtuzumab | Anti-Human LOXL2 Recombinant Antibody (Simtuzumab) | TAB-890 | Simtuzumab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
NCAM1 | Lorvotuzumab Mertansine | Humanized Anti-NCAM1 Recombinant Antibody (clone Lorvotuzumab) | TAB-188 | Lorvotuzumab Mertansine Overview |
NGCGM3 | Racotumomab | Anti-Human NGcGM3 Recombinant Antibody (Racotumomab) | TAB-H58 | Racotumomab Overview |
NOTCH1 | Brontictuzumab | Anti-Human NOTCH1 Recombinant Antibody (Brontictuzumab) | TAB-H11 | Brontictuzumab Overview |
NRP1 | Vesencumab | Anti-Human NRP1 Recombinant Antibody (Vesencumab) | TAB-264 |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
PcrV | Rivabazumab | Anti-Pseudomonas Aeruginosa pcrV Recombinant Antibody Fab Fragment (Rivabazumab) | TAB-472CQ | Rivabazumab Overview |
PCSK9 | Bococizumab | Anti-Human PCSK9 Recombinant Antibody (Bococizumab) | TAB-H10 | Bococizumab Overview |
PCSK9 | Lodelcizumab | Anti-PCSK9 Recombinant Antibody (Lodelcizumab) | TAB-758 | |
PDGFRA | Olaratumab | Anti-Human PDGF-R alpha Recombinant Antibody (Olaratumab) | TAB-192 | Olaratumab Overview |
PDGFRA | Tovetumab | Anti-Human CD140a Recombinant Antibody (Tovetumab) | TAB-878 |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
RSPO3 | Rosmantuzumab | Anti-Human RSPO3 Recombinant Antibody (Rosmantuzumab) | TAB-449CQ | Rosmantuzumab Overview |
Target | INN | Product Name | Product CAT | Overview |
---|---|---|---|---|
S. epidermidis LTA | Pagibaximab | Anti-S. Epidermidis LTA Recombinant Antibody (Pagibaximab) | TAB-H53 | Pagibaximab Overview |
SELL | Aselizumab | Anti-SELL/CD62L Recombinant Antibody (Aselizumab) | TAB-720 | Aselizumab Overview |
SELP | Inclacumab | Anti-Human selectin P Recombinant Antibody (Inclacumab) | TAB-246 | Inclacumab Overview |
SLAMF7 | Elotuzumab | Anti-SLAMF7 Recombinant Antibody (Elotuzumab) | TAB-743 | Elotuzumab Overview |
The development of biosimilars for complex mAbs, which are the highest-selling biologics and is a key therapeutic class for diseases including various cancers and autoimmune disorders such as rheumatoid arthritis, is accelerating rapidly owing to the upcoming patent expiry of top-selling drugs. Despite technical and manufacturing hurdles, these complexand large molecules especially antibody-based proteins are poised to be the leaders of the new wave of biosimilars that are likely to receive approval in the coming years. Driven by the prospect of patent expirations of blockbuster mAbs in the next few years (Table 1), many pharmaceutical companies have entered the rapidly growing mAb biosimilars market.
Table 1 Selected key products for which monoclonal antibody biosimilars are in development
*The date given is based on the expected expiry of patents protecting the original molecule.
Biosimilars are a huge opportunity. The market will eventually become a huge business no matter how slowly it starts. There are several elements to boost biosimilars’ market growth including patent expiries, defined regulatory pathways and escalating healthcare costs. According to some professional investigational agency, it is estimated that biologic drugs worth $70-$80 billion will lose exclusivity in the next 5 years globally. Moreover, the launch of innovation production platforms will reduce the cost of biosimilars production, thus providing substantial price differentiation. In the next 4 to 5 years, two-thirds of the patents will expire in biosimilars and specialty segments, such as high profit margins of biomedical fields.
To boost your biosimilar research programs, Creative Biolabs provides a full range of therapeutic antibodies currently available for research of a wide variety of diseases. We have rich experience for over 10 years to offer high quality antibodies that will meet your any requirement.
References
For research use only. Not intended for any clinical use.
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