---
title: Biosimilars
description: Development and Analysis of Biosimilars and Follow-On Biologics, cytokine and anti cytokine drugs, cancer drugs, bioassays, recombinant protein production
---

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# Biosimilars

Development and Analysis of Biosimilars and Follow-On Biologics

The patent expiration of over 20 blockbuster biologics in the next 10 years, coupled with easier/newer FDA regulations, will lead to significant opportunities for biosimilars and follow-on biologics. SBH Sciences is in a privileged position to assist companies developing biologicals, including monoclonal antibodies such as anti-TNF-alpha and anti-VEGF, recombinant proteins like Interferon's, Erythropoietin's (EPO), G-CSF agents, and other cytokine-based drugs. These cytokine drugs, essential in medical research and therapy, especially in cancer treatment, utilize cytokines- small proteins crucial for cell interactions and the immune response. Their ability to modulate the immune system is invaluable in targeting cancer cells, and their integration into our development services aligns with current advancements in cancer treatment. By harnessing and modifying these natural signaling molecules, cytokine drugs can enhance or suppress the immune response, depending on the therapeutic need. In cancer therapy, they are often used to boost the immune system's ability to recognize and destroy cancer cells. This approach has led to significant advancements in the treatment of various types of cancer, offering hope where traditional therapies have fallen short. Below, find two tables outlining some examples of FDA approved and clinically investigated cytokine and anti-cytokine \[usually monoclonal antibodies\] drugs.

Approved Cytokine Drug and Cytokine currently in clinical trials

| **Cytokine ** | **Drug** | **Brand(s)** | **Indication ** | **Approved / Investigational** |
| --- | --- | --- | --- | --- |
| bFGF | Basic Fibroblast Growth Factor | - | peripheral arterial disease (PAD), periodontitis, stomatitis, tympanic membrane perforation, wound healing | Investigational  |
| G-CSF | Filgrastim | Accofil, Granix, Grastofil, Neupogen, Nivestim, Nivestym, Ratiograstim, Releuko, Zarxio, Zarzio | infection and febrile neutropenia post chemotherapy  | Approved |
| G-CSF | Efbemalenograstim alfa | Ryzneuta | infection and febrile neutropenia post chemotherapy  | Approved |
| GM-CSF | Sargramostim | Leukine  | cancer, bone marrow transplant | Approved |
| GM-CSF | Regramostim | - | adverse effects of chemotherapy and bone marrow transplant  | Investigational  |
| IFNα-2a | Interferon alfa-2a | Roferon A, Veldona | hepatitis, hairy cell leukemia, chronic myelogenous leukemia, AIDS-related Kaposi's sarcoma | Approved |
| IFNα-2b | Interferon alfa-2b | Intron A | hepatitis, genital warts, hairy cell leukemia, follicular lymphoma malignant melanoma, AIDS-related Kaposi's sarcoma | Approved |
| IFNα-2c | Interferon alfa-2c | - | progressive metastatic renal cell carcinoma | Investigational  |
| IFNβ-1a | Interferon beta-1a | Avonex, Rebif | multiple sclerosis  | Approved |
| IFNβ-1b | Interferon beta-1b | Betaferon, Betaseron, Extavia | multiple sclerosis  | Approved |
| IL-2 | Aldesleukin | Proleukin  | metastatic renal cell carcinoma  | Approved |
| IL-7 | Interleukin-7 | - | metastatic breast cancer | Investigational  |
| IL-10 | Interleukin-10 | - | vasculitis, pancreatitis, bile duct diseases, pancreatic diseases, gallbladder diseases | Investigational  |
| IL-11 | Oprelvekin | Neumega | thrombocytopenia post chemotherapy | Approved |
| MIP-1α | Nagrestipen | - | cancer, tumor metastasis  | Investigational  |

 

Approved Anti-Cytokine Drug and Anti-Cytokine currently in clinical trials

 

| **Anti-Cytokine ** | **Drug** | **Brands** | **Indication ** | **Approved / Investigational** |
| --- | --- | --- | --- | --- |
| EGFR | Cetuximab | Erbitux | squamous cell carcinoma of the head and neck | Approved |
| EGFR | Panitumumab | Vectibix | metastatic colorectal carcinoma  | Approved |
| IL-1R | Anakinra | Kineret | rheumatoid arthritis, neonatal-onset multisystem inflammatory disease and deficiency of interleukin-1 receptor antagonist (DIRA) | Approved |
| IL-6R | Tocilizumab | Actemra, RoActemra | cytokine release syndrome, systemic juvenile idiopathic arthritis, giant cell arteritis, rheumatoid arthritis | Approved |
| IL-12/IL-23 | Ustekinumab | Stelara | plaque psoriasis, psoriatic arthritis, Chron's disease, ulcerative colitis  | Approved |
| IL-13 | Cendakimab | - | eosinophilic esophagitis | Investigational  |
| IL-13 | Lebrikizumab | - | atopic dermatitis, asthma, idiopathic pulcomary fibrosis, COPD | Investigational \[EU Approved\] |
| IL-13 | Tralokinumab | Adbry | atopic dermatitis | Approved |
| IL-13R | Eblasakimab | - | atopic dermatitis | Investigational  |
| IL-23 | Mirikizumab | Omvoh | ulcerative colitis  | Approved |
| TNF-α | Adalimumab | Amjevita, Cyltezo, Humira, Hyrimoz, Yusimry | rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, ankylosing spondylitis, hidradenitis suppurativa Crohn's disease, ulcerative colitis  | Approved |
| TNF-α | Certolizumab pegol | Cimzia | Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, non-radiographic axial spondylarthritis | Approved |
| TNF-α | Golimumab | Simponi | rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis  | Approved |
| TNF-α | Infliximab  | Avsola, Flixabi, Inflectra, Remicade, Renflexis | Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis  | Approved |
| TNF-αR | Etanercept | Enbrel, Eticovo | rheumatoid arthritis, plaque psoriasis  | Approved |
| VEGF | Bevacizumab | Avastin | metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, cervical cancer, primary peritoneal cancer, epithelial ovarian cancer, fallopian tube cancer, breast cancer, glioblastoma | Approved |
| VEGFR2 | Ramucirumab | Cyramza | gastric cancer, metastatic colorectal caner, on-small cell lung cancer, hepatocellular carcinoma  | Approved |

 

SBH Sciences has the expertise needed to speed up and implement accurate and reproducible bioassays, crucial for the final product release of these complex biologics. We are offering bioassays for over 330 cytokines and can assist with all the cytokine / anti-cytokine drugs described in the Tables below. In addition, we can assist in the lead drug development process, which includes cell culture, protein purification, ELISA-based assay, analytical HPLC, formulation, and stability studies, as well as drug delivery studies. This includes the development and analysis of cytokine drugs, which have shown promise in enhancing or suppressing the immune response based on therapeutic needs, thus opening new avenues in cancer therapy and beyond.

For more information, please visit our [Production of Biologics](https://sbhsciences.com/protein-production-services) page.

Please [contact us](https://sbhsciences.com/contact) to discuss your specific needs and explore how SBH Sciences can assist you with the latest advancements in biologics, including cytokine drug development.

Our expertise is your competitive edge in harnessing these innovative treatments.

 

 

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