About Us | Biosimilar India - Mumbai Biocluster

Our Story

Who We Are

A closer look at how Biosimilar Inida works, who we work with, and the principles that shape every project we take on.

An initiative by Mumbai Biocluster, BiosimilarIndia serves as a premier collaborative hub for biosimilar innovation.

Mumbai Biocluster is a Section 8 - not for profit company established in strategic partnership with Institute of Chemical Technology (ICT), Mumbai, we provide comprehensive, end-to-end development services through high-precision science.

Our organization is built on a foundation of scientific rigor and regulatory excellence. We specialize in navigating the complexities of Monoclonal Antibodies (mAb), Peptide & Protein biosimilars and regulatory strategy for clinical waiver, offering comprehensive solutions that support every stage of project lifecycles, from initial design to regulatory submission.

We operate under a stringent ‘Totality-of-Evidence’ framework, ensuring every project aligns with global regulatory guidelines.

Our team combines decades of experience in biosimilar development, regulatory strategy, and analytical characterization. This collective expertise allows us to provide high-quality, cost-effective solutions tailored to the unique needs of our partners.

MBC / Profile — ICT Mumbai Partnership

Founding Partner

Institute of Chemical Technology, Mumbai

Operating Framework

Totality-of-Evidence

Core Focus Areas

mAb · Peptide & Protein · Regulatory Strategy

Service Model

Fee-For-Service, Design Through Submission

Our Mission

Our mission is to enable affordable access to complex biologics development by integrating cutting-edge technology with deep scientific expertise, delivering high-quality solutions to global markets with speed and precision.

Our Vision

We envision an ecosystem where every biosimilar program benefits - as a standard, not an exception - from the precision of academic-grade characterization and the discipline of industry-grade delivery.

How We Operate

The Principles Behind Our Work

Commitments that shape every program we take on, from the first conversation to the final report.

01

Regulatory Rigor

Every characterization decision is made with ICH Q5E, Q6B, and biosimilarity guidance in mind, not retrofitted later.

02

Scientific Depth

Structural, functional, and bioanalytical characterization go beyond checkbox testing to build a genuine weight-of-evidence case.

03

Academic-Industry Bridge

Our ICT Mumbai partnership pairs research-grade instrumentation with the delivery discipline an industry sponsor expects.

Our Team

Meet Our Experts

Our team combines decades of experience in biosimilar development, regulatory strategy, and analytical characterization. We are committed to delivering high-quality, cost-effective solutions tailored to your needs.