Biosimilars

The patent expiration of over 20 blockbuster biologics over the next decade, coupled with increasingly navigable FDA regulations, presents significant opportunities for the development of biosimilars and follow-on biologics.

Biosimilar Development and Analysis Services at SBH Sciences

SBH Sciences is uniquely positioned to assist companies developing biologicals, including:

Monoclonal antibodies
- Anti-TNF-alpha, anti-VEGF

Recombinant proteins
- Interferon’s
- Erythropoietin’s (EPO)
- G-CSF agents

Biosimilars in Oncology

Cytokine-based drugs play an essential role in medical research and therapeutic development, particularly in oncology. These small, naturally occurring proteins are key regulators of immune responses and cell signaling.

Their ability to stimulate or suppress the immune system makes them invaluable in targeting 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, are two tables highlighting examples of FDA approved and clinically investigated cytokine and anti-cytokine (typically monoclonal antibodies) drugs.

Our CRO Biosimilar Services

SBH Sciences has the expertise to accelerate and implement accurate, reproducible bioassays, critical for the final product release of complex biologics. We offer bioassay services for over 350 cytokines and are well-equipped to support the development and analysis of all cytokine and anti-cytokine drugs featured in the tables below.

We provide comprehensive support during the lead drug development process, including:

• Cell culture
• Protein purification
• ELISA-based assays
• Analytical HPLC
• Formulation and stability studies
• Drug delivery studies

Our services extend to the development and analysis of cytokine drugs, which can be engineered to enhance or suppress the immune system based on therapeutic needs.

For more information, please visit our Protein Services page

Cytokine-Based Drugs: FDA Approvals and Clinical Pipeline

Cytokine	Drug	Brand(s)	Indication	Approved / Investigational
bFGF	Basic FibroblastGrowth Factor	-	peripheral arterialdisease (PAD), periodontitis, stomatitis, tympanic membrane perforation,wound healing	Investigational
G-CSF	Filgrastim	Accofil,Granix, Grastofil, Neupogen, Nivestim, Nivestym, Ratiograstim, Releuko,Zarxio, Zarzio	infectionand febrile neutropenia post chemotherapy	Approved
G-CSF	Efbemalenograstimalfa	Ryzneuta	infection andfebrile neutropenia post chemotherapy	Approved
GM-CSF	Sargramostim	Leukine	cancer,bone marrow transplant	Approved
GM-CSF	Regramostim	-	adverse effects ofchemotherapy and bone marrow transplant	Investigational
IFNα-2a	Interferonalfa-2a	Roferon A,Veldona	hepatitis,hairy cell leukemia, chronic myelogenous leukemia, AIDS-related Kaposi'ssarcoma	Approved
IFNα-2b	Interferon alfa-2b	Intron A	hepatitis, genitalwarts, hairy cell leukemia, follicular lymphoma malignant melanoma,AIDS-related Kaposi's sarcoma	Approved
IFNα-2c	Interferonalfa-2c	-	progressive metastatic renal cellcarcinoma	Investigational
IFNβ-1a	Interferon beta-1a	Avonex, Rebif	multiplesclerosis	Approved
IFNβ-1b	Interferonbeta-1b	Betaferon,Betaseron, Extavia	multiple sclerosis	Approved
IL-2	Aldesleukin	Proleukin	metastatic renalcell carcinoma	Approved
IL-7	Interleukin-7	-	metastaticbreast cancer	Investigational
IL-10	Interleukin-10	-	vasculitis,pancreatitis, bile duct diseases, pancreatic diseases, gallbladder diseases	Investigational
IL-11	Oprelvekin	Neumega	thrombocytopeniapost chemotherapy	Approved
MIP-1α	Nagrestipen	-	cancer, tumormetastasis	Investigational

Anti-Cytokine Therapies: FDA Approvals and Clinical Pipeline

Anti-Cytokine	Drug	Brands	Indication	Approved / Investigational
EGFR	Cetuximab	Erbitux	squamous cellcarcinoma of the head and neck	Approved
EGFR	Panitumumab	Vectibix	metastatic colorectalcarcinoma	Approved
IL-1R	Anakinra	Kineret	rheumatoid arthritis,neonatal-onset multisystem inflammatory disease, deficiency of interleukin-1receptor antagonist (DIRA)	Approved
IL-6R	Tocilizumab	Actemra,RoActemra	cytokinerelease syndrome, systemic juvenile idiopathic arthritis, giant cellarteritis, rheumatoid arthritis	Approved
IL-12/IL-23	Ustekinumab	Stelara	plaque psoriasis,psoriatic arthritis, Chron's disease, ulcerative colitis	Approved
IL-13	Cendakimab	-	eosinophilicesophagitis	Investigational
IL-13	Lebrikizumab	-	atopic dermatitis,asthma, idiopathic pulmonary fibrosis, COPD	Investigational [EUApproved]
IL-13	Tralokinumab	Adbry	atopicdermatitis	Approved
IL-13R	Eblasakimab	-	atopic dermatitis	Investigational
IL-23	Mirikizumab	Omvoh	ulcerativecolitis	Approved
TNF-α	Adalimumab	Amjevita, Cyltezo,Humira, Hyrimoz, Yusimry	rheumatoid arthritis,juvenile idiopathic arthritis, plaque psoriasis, ankylosing spondylitis, hidradenitissuppurativa Crohn's disease, ulcerative colitis	Approved
TNF-α	Certolizumabpegol	Cimzia	Crohn'sdisease, 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'sdisease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis,psoriatic arthritis, plaque psoriasis	Approved
TNF-αR	Etanercept	Enbrel, Eticovo	rheumatoid arthritis,plaque psoriasis	Approved
VEGF	Bevacizumab	Avastin	metastaticcolorectal cancer, non-squamous non-small cell lung cancer, metastatic renalcell carcinoma, cervical cancer, primary peritoneal cancer, epithelialovarian cancer, fallopian tube cancer, breast cancer, glioblastoma	Approved
VEGFR2	Ramucirumab	Cyramza	gastric cancer,metastatic colorectal cancer, on-small cell lung cancer, hepatocellularcarcinoma	Approved