Product
Overview

NeuClone is developing a deep pipeline of analytically proven biosimilars across a range of indications, aimed at both developed and rest-of-world (RoW) markets.

 

The five disclosed products we are developing in partnership with Serum Institute of India represent a combined global market of over $30 billion.

 

Below are the reference product details of these five biosimilars.

Herceptin

INN name

Trastuzumab

 

Reference Product Indications

HER2 overexpressing breast and gastric cancer.

 

Mechanism of Action

HER2/neu receptor antagonist

 

Global Sales (USD)

2017: $7.4 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

Preclinical analytical and toxicokinetic studies demonstrated high biosimilarity.

cGMP clinical manufacture completed.

Phase I with globally recognised CRO imminent.

Stelara

INN name

Ustekinumab

 

Reference Product Indications

Plaque psoriasis

Psoriatic arthritis

Crohn’s disease

 

Mechanism of Action

IL-12 and IL-23 antagonist

 

Global Sales (USD)

2017: $4.0 billion

2022E: $4.9 billion[9]

 

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

Analytical biosimilarity confirmed by Tier 1-3 tests and structure confirmation achieved through X-ray crystallography analysis.

Completing process scale-up in preparation for clinical Phase I clinical trials in 2019.

Preclinical toxicokinetic studies imminent.

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

 

2017 Global Sales (USD)

$3.5 billion

2022E: $5.6 billion[8]

 

Patient Numbers

Over 200 million people worldwide suffer from osteoporosis.[19]

 

Development Status

Selection of clone with potential to achieve >3 g/L titre.

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)

2017: $18.9 billion

2020E: $21.0 billion[10]

 

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

Selection of clone with potential to achieve >3 g/L titre.

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)

2017: $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

Selection of clone with potential to achieve >3 g/L titre.

Learn more about what we do

Download NeuClone Brochure

 

Ellipse2_background-01