Product
NeuClone is developing a deep pipeline of over 20 biosimilars across a range of indications for global markets. Below are the reference product details of our eight publicly disclosed biosimilars.
Stelara
INN name
Ustekinumab
Reference Product Indications
Plaque psoriasis
Psoriatic arthritis
Crohn’s disease
Ulcerative colitis
Mechanism of Action
IL-12 and IL-23 antagonist
Global Sales (USD)
2020: $8.0 billion
Patient Numbers
The prevalence of psoriasis is between 1.5% and 5% in most developed countries.[14] 7.4 million adults in the U.S. live with psoriasis.[15]
Development Status
Phase I clinical trial successfully completed. All primary and secondary endpoints achieved.
Herceptin
INN name
Trastuzumab
Reference Product Indications
HER2 overexpressing breast and gastric cancer.
Mechanism of Action
HER2/neu receptor antagonist
Global Sales (USD)
2020: $4.0 billion
Patient Numbers
Roughly 20% of breast and gastric cancers are HER2-positive[11][12]. Breast cancer is the second most common cancer in the world with approximately 1.7 million new cases diagnosed per year.[13]
Development Status
Phase I clinical trial successfully completed. All primary and secondary endpoints achieved.
Perjeta
INN name
Pertuzumab
Reference Product Indications
HER2-positive metastatic and early breast cancer. Approved for use in combination with trastuzumab.
Mechanism of Action
HER2 (subdomain II)
Global Sales (USD)
2020: $4.2 billion
2024E: $5.9 billion[20]
Patient Numbers
Roughly 20% of breast cancers are HER2-positive[12]. Breast cancer is the second most common cancer in the world with approximately 1.7 million new cases diagnosed per year [13].
Development Status
Process development and scale-up activities in progress.
Prolia/XGEVA
INN name
Denosumab
Reference Product Indications
Increasing bone mass in osteoporosis
Treatment-induced bone loss
Multiple myeloma and solid tumour metastases to bone
Giant cell tumour of bone
Hypercalcemia of malignancy
Mechanism of Action
RANK ligand inhibitor
Global Sales (USD)
2020: $5.1 billion
2024E: $6.0 billion[20]
Patient Numbers
Over 200 million people worldwide suffer from osteoporosis.[19]
Development Status
Process development and scale-up activities in progress.
Keytruda
INN name
Pembrolizumab
Reference Product Indications
Over ten oncology indications including melanoma, lung cancer and renal cell carcinoma.
Mechanism of Action
Programmed death receptor-1 (PD-1)-blocking antibody.
Global Sales (USD)
2020: $14.4 billion
2024E: $22.3 billion [22]
Patient Numbers
There were approximately 2 million new cases of lung cancer and 300,000 new cases of melanoma worldwide in 2018 [23],[24].
Development Status
Process development and scale-up activities in progress.
Synagis
INN name
Palivizumab
Reference Product Indications
Prevention of lower respiratory tract disease in premature babies and other infants at risk of RSV infection
Mechanism of Action
RSV protein F glycoprotein inhibitor
Global Sales (USD)
2020: $1.1 billion
Patient Numbers
RSV causes roughly 34 million cases of acute respiratory illness in children under 5 years of age globally.[18]
Development Status
Process development and scale-up activities in progress.
Opdivo
INN name
Nivolumab
Reference Product Indications
Ten oncology indications including melanoma, lung cancer and renal cell carcinoma.
Mechanism of Action
Programmed death receptor-1 (PD-1)-blocking antibody.
Global Sales (USD)
2020: $7.9 billion
2024E: $10.5 billion [22]
Patient Numbers
There were approximately 2 million new cases of lung cancer and 300,000 new cases of melanoma worldwide in 2018 [23],[24].
Development Status
Late preclinical.
Humira
INN name
Adalimumab
Reference Product Indications
Rheumatoid arthritis
Juvenile idiopathic arthritis
Psoriatic arthritis
Ankylosing spondylitis
Crohn’s disease
Ulcerative colitis
Plaque psoriasis
Hidradenitis suppurativa
Uveitis
Mechanism of Action
TNF-α blocker
Global Sales (USD)
2020: $20.4 billion
Patient Numbers
The global prevalence of Rheumatoid Arthritis is roughly 17 million.[16] Inflammatory bowel disease (comprising ulcerative colitis and Crohn’s disease) affects over 1.6 million people in the U.S. alone.[17]
Development Status
Late preclinical.
