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 page.

Please contact us 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.