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R&D-driven manufacturing delivered globally
Scaling complex biosimilar development through deep chemical expertise, integrated software, and high-precision manufacturing capacity.
Trusted by 50+ Industry Partners
Who We Are
An initiative by Mumbai Biocluster, BiosimilarIndia serves as a premier collaborative hub for biosimilar innovation. Established in strategic partnership with Institute of Chemical Technology (ICT), Mumbai, we provide comprehensive, end-to-end development services through high-precision science.
Accurate and accelerated delivery
Right-sized infrastructure and coordinated workflows across the ecosystem mean faster development cycles - without compromising the science behind them
Heavily de-risked Biotherapeutic development
Every program is built on validated processes and orthogonal analytical checks - surfacing risks early, not after they've become costly delays.
Transparent, Collaborative Partnership
Study design, data, and decisions are shared openly at every stage - so you stay in control of your program, not just informed about it after the fact.
Regulatory Pragmatism
Pre-submission consultation support across FDA, EMA, and CDSCO - so dossiers are built for agency acceptance from day one, not retrofitted after review..
How we can help you
We provide comprehensive end-to-end solutions for biosimilar development, from analytical characterization to process optimization and regulatory support. Our services include:
Monoclonal Antibody (mAb) Biosimilars
End-to-End Bioprocess & Characterization
- CHO Cell Line Development
- Upstream Process Development
- Downstream Process Development
- Analytical & Bioanalytical Characterization (mAbs)
Peptide & Protein biosimilars
Analytical & Bioanalytical Services
- Peptide Sameness & Structural Characterization
- Higher Order Structure (HOS) Analysis
- Bioanalytical & Functional Characterization
- Formulation & Stability Studies
Regulatory Strategy for Clinical Waiver
Regulatory & CMC Advisory
- Totality-of-Evidence dossier building
- Statistical similarity assessment
- CMC module preparation (Module 3)
- Pre-submission consultation support