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Our work in Biosimilars


Biocon Biologics is a vertically integrated, innovation-led company with established capabilities in the development, manufacturing and commercialization of affordable, high-quality biologics.

We are driven by the business purpose of providing equitable access to healthcare through affordable biologics.

We have a proven track record of scientific credibility, large scale manufacturing capabilities and a strong supply & distribution network in compliance with the highest standards of quality and governance.

We have demonstrated success with multiple successful biosimilar approvals in U.S., Europe and several other developed and developing countries.

Broad Portfolio of Biosimilars

We are leveraging our cutting-edge science, innovative tech platforms, advanced research & development capabilities to lower treatment costs while improving healthcare outcomes worldwide.

We have one of the broadest and deepest portfolios of biosimilars in the industry, monoclonal antibodies for cancer and autoimmune diseases, insulin and insulin analogs for diabetes and conjugated recombinant proteins for cancer. Our significant investments in R&D have yielded several molecules in diabetes, oncology, and immunology of which seven have been already commercialized in markets globally[1] . We were the first company to receive U.S. Food and Drug Administration’s (FDA) approval for biosimilar Trastuzumab and biosimilar Pegfilgrastim. We are also the first to obtain U.S. FDA approval of the world’s first interchangeable biosimilar, received for our Insulin Glargine.

To provide patients access to affordable biologics and enable health equity, Biocon Biologics is developing a strong portfolio of 20 biosimilar assets, including partnered assets, as well as the ones we are developing independently. These assets address a USD 70 billion[2] global market opportunity by FY27.

Fully Integrated from Lab to Market

We are developing high-quality and affordable biosimilars that can expand access to cutting-edge therapeutics for patients globally at our R&D sites in Bengaluru and Chennai (India). These are manufactured at scale for both developed and emerging markets in Bengaluru (India) and Johor (Malaysia). Our products are marketed globally through a hybrid commercial model, wherein we have direct commercial presence in a few countries and in others, we leverage partners. Our biosimilars currently reach patients in over 75 countries.

Capacity Aligned with Expanding Global Demand

We have created global scale capacities for insulins and antibodies that meet the most stringent of regulatory norms. Biocon Biologics is one of the largest producers of biosimilars in Asia. Furthermore, we are the third largest producers of Insulins globally and the only Indian company that has brought biosimilars to the U.S. and European markets.

A Transformative Acquisition

We are nearing the completion of our acquisition of the global biosimilars business of our long-term partner Viatris for USD 3.335 billion in cash and stock. This acquisition is a transformational inflection point that steers us into accelerated, inorganic business expansion.

This game-changing transaction will create a world leader in the biosimilars space and will enable us to seamlessly move from the current collaboration model to full ownership of Viatris’ rights in partnered and in-licensed biosimilars assets.

Furthermore, it will enable full vertical integration across the biosimilars value chain from lab to market and take us closer to patients, payors and healthcare providers in developed and emerging markets.

Expansion into Adjacencies

Biocon’s quest to impact global healthcare has steered us towards a strategic expansion into adjacencies such as vaccines. We have entered into an alliance with Serum Institute Life Sciences (SILS) to join the effort of addressing the inequitable access to vaccines.

[1] Includes in-licensed programs (bAdalimumab and bEtanercept)
[2] Market opportunity size of Biocon Biologics’ portfolio based on reported CY 2021 sales of originator brands and biosimilars

Key Highlights

Biosimilars portfolio spans rh-insulin, insulin analogs, mAbs and other recombinant proteins.

15+ years of experience in developing biologics with strong scientific and technical capabilities.

5,000+ people dedicated to support this business across various functions.

7 biosimilars commercialized in markets globally – Trastuzumab, Pegfilgrastim, Bevacizumab, rh-Insulin, Insulin Glargine, Adalimumab#, Etanercept#.

2.75+ billion doses of Recombinant human insulin provided to patients globally since 2004.

5.51 million* patients reached through our products (MAT June 2022)*

# In-licensed molecules
* Number of patients is calculated based on volume supplied