Biosimilar Products

National Biopharma Mission aims to accelerate the development of cost effective, safe and efficacious biosimilars of monoclonal antibodies and other therapeutic proteins that have high market scope, addresses India’s disease burden and are feasible for development based on patent expiry of original biotherapeutic (2015-2020 US/EU) or not patent protected in India. The biosimilars supported under this call are for diseases like cancer, Type I and Type II diabetes, rheumatoid arthritis and age-related wet AMD.

Therapeutic Area/ Name of Product

Name of grantee

Development Phase Supported

Environmental and Health Risk Management Plan (EHRMP)

Diabetes/ Insulin Glargine

Vitane Biologics Pvt. Ltd.

Preclinical

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Emergency situations/ Human Serum Albumin

BIBCOL

National Institute of Immunology

Preclinical

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Cancer/ Trastuzumab Serum Institute of India Pvt. Ltd. Preclinical  Click Here
Liraglutide Levim Biotech LLP Process scale upto 200 L scale and Phase III Clinical Trial  Click Here
Wet-AMD/Ranibizumab National Chemical laboratory (NCL), Pune Process development and Analytical method development  Click Here
Wet-AMD/Ranibizumab Indian institute of Technology (IIT), Delhi Process development and Analytical method development  Click Here
Diabetes/Insulin Glargine Stelis Biopharma Pvt Ltd GMP manufacturing & clinical development  Click Here
rHU Biosimilar Insulin Lispro National Chemical laboratory (NCL), Pune and Indian institute of Technology (IIT), Delhi Preclinical  Click Here
Psoriatic Arthritis/Ustekinumab Serum Institute of India Pvt Ltd Preclinical to Clinical  Click Here
Lung infections caused by RSV/Palivizumab Serum Institute of India Pvt Ltd Preclinical to Clinical  Click Here
Wet-AMD/Aflibercept Lupin Ltd Preclinical to Clinical Click Here