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Biocon  /  Businesses  /  Biosimilars  /  Our work in Biosimilars


Our work in Biosimilars


Biocon Biologics Limited (BBL) is a fully integrated, innovation-led company committed to transforming patients’ lives by enabling affordable access to high-quality biosimilars for patients and healthcare systems, either directly or through a network of partners and distributors, in over 100+ countries.

BBL has demonstrated success with multiple successful biosimilar approvals in U.S., Europe and several other advanced and developing countries. It has eight [1] commercialized products in global markets. It is the first company in the world to obtain U.S. Food and Drug Administration (FDA) approval for an interchangeable biosimilar, received for its Insulin Glargine.

The company has a broad pipeline of 20 biosimilar molecules spanning insulins, monoclonal antibodies and conjugated recombinant proteins with a strong focus on diabetology, oncology and immunology, targeting an over USD 70 billion addressable market by FY27 [2].

Through its recent strategic alliance with the Serum Institute Life Sciences (SILS), BBL will be able to diversify its business beyond biosimilars and have access to a portfolio of vaccines targeting several communicable diseases.

Biocon Biologics has invested over USD 1 billion to date in R&D and global scale manufacturing and has end-to-end capabilities for producing drug substance, drug product and delivery devices across multiple sites in India and Malaysia.

It is also among the Top 15 global biopharma players in terms of installed capacity and has a strong track record of compliance and quality with GMP certifications and approvals from key regulators such as U.S. FDA, European Medicines Agency, Therapeutic Goods Administration (Australia), Health Canada, PMDA (Japan) and many others.

Biocon Biologics is committed to Environmental, Social, and Governance initiatives with clear annual targets for key metrics such as the use of renewable energy, expanding access to biosimilars in low- and middle-income countries (LMICs) and gender diversity.

People are core to BBL’s mission and success. It remains committed to employee-centric policies, building a diverse and inclusive workplace culture, and investing in talent through various initiatives and programs.

Apart from the parent company, Biocon Biologics’ investors include Goldman Sachs, True North, Tata Capital, Abu Dhabi Development Holding Company (ADQ), Serum (subject to closing of the previously announced merger with Covidshield Technologies, a wholly owned subsidiary of Serum) and Viatris.

Broad Portfolio of Biosimilars

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

It is the first company in the world to develop a biosimilar recombinant human insulin using a proprietary Pichia pastoris platform in 2004 and has proven scientific expertise across multiple technology platforms and formats.

Today, Biocon Biologics has a portfolio of biosimilar assets, including insulins, monoclonal antibodies and conjugated recombinant proteins in therapeutic areas such as diabetology, oncology, immunology, and ophthalmology, which is one of the broadest and deepest biosimilar portfolio in the industry.

Fully Integrated from Lab to Market

BBL is developing high-quality and affordable biosimilars that can expand access to cutting-edge therapeutics for patients globally at its R&D sites in Bengaluru and Chennai (India). These are manufactured at scale for both advanced and developing countries at its state-of-the-art biologics manufacturing facilities in Bengaluru (India) and Johor (Malaysia).

Biocon Biologics is ranked among the world’s Top 15 biomanufacturing companies. The breadth and scale of its manufacturing technologies encompass large-scale microbial fermentation, chemical synthesis, mammalian cell culture, protein & antibody purification, aseptic formulation, and fill-finish. BBL is among the leading insulin producers worldwide and has one of South Asia’s largest antibodies manufacturing capacities.

The company’s products are marketed globally through a hybrid commercial model with a combination of direct presence, strategic partnerships and distributor tie-ups.

A Transformative Acquisition

Biocon Biologics has completed a transformative acquisition of its long-term partner Viatris’ global biosimilars business for over USD 3 billion in cash and stock.

After a decade long, strong relationship between Biocon and Viatris (formerly Mylan) for co-developing and commercializing high-quality biosimilars in global markets, this was a natural progression in BBL’s value creation journey.

With this acquisition, Biocon Biologics has emerged as a unique, fully integrated, global biosimilars player, which is well-positioned to provide equitable access to high-quality, life-saving biosimilar medicines to patients.

Through full integration across the biosimilars value chain from lab to market, this acquisition takes BBL closer to patients, payors and healthcare providers in advanced and emerging markets.

[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

Unique Biosimilars portfolio spanning rh-insulin, insulin analogs, monoclonal antibodies and conjugated recombinant proteins.

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

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

~5.7 million* patients reached through our products (MAT March 2023)*

Cutting-edge science & research capabilities, resulting in several global ‘firsts’ in the biosimilars industry.

Among the Top 15 global  biopharma players in terms of bio-manufacturing capacity.

High standards of quality & compliance. 25+ cGMP approvals from  international regulatory agencies.

~6,500+ people  dedicated to support this business across various functions.

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

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