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Biocon’s Bold Integration: Unifying Biosimilars and Generics to Redefine Global Affordable Access
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by Shreehas Tambe
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| Setting the Stage | Healthcare systems across the world are under growing pressure—from rising costs and increasing disease burden to persistent gaps in access. Addressing these challenges at scale requires scientific innovation alongside integrated, efficient models that deliver consistent sustainable access and affordability across the continuum of care. Having spent nearly three decades helping build Biocon’s global capabilities, I have seen first-hand the responsibility that comes with scale and scientific excellence. Inspired by our founder Kiran Mazumdar-Shaw’s vision that access to healthcare should never be
defined by income or geography, we are committed to translating our scale and science into access for patients and resilience for healthcare systems. Today, Biocon is taking a decisive step forward. By integrating our biosimilars and generics businesses under one unified structure, we are building a platform designed to expand access to affordable medicines with greater speed, efficiency, and reach. | | Building a Unified Platform for Increased Access | Biocon’s integration of its biosimilars and generics businesses, effective as of April 1, creates a global biopharma enterprise that is uniquely positioned to lead in diabetes, oncology and immunology —
therapeutic areas with significant unmet needs that together account for nearly 40% of global pharmaceutical revenues. The integration reflects a growth trajectory that has been remarkable. Since acquiring Viatris’ biosimilars business, Biocon has expanded its commercial and operational footprint to more than 120 countries reaching 21 million patients in the last fiscal year. These numbers are the result of a vertically integrated, lab-to-patient player with global capabilities combining
R&D, manufacturing, commercial execution, and a robust portfolio that few companies can replicate. | | Growth in Biosimilars | Biosimilars are redefining the future of affordable healthcare. Millions of patients who previously faced barriers to treatment now have access to life-changing medicines. They represent a transformative opportunity to deliver and access and affordability for millions of patients worldwide. Here in the U.S., biosimilars have delivered $56 billion in savings since market entry in 2015 and the sales price of a
biosimilar is, on average, 50% less than the reference brand biologic price at the time of biosimilar launch. This has led to improved access and affordability for millions already. Biocon is at the forefront of this biosimilar revolution. In oncology, we are making a measurable difference. In the U.S., we launched denosumab biosimilars Bosaya™ and Aukelso™
(originator names are Prolia® and Xgeva®, respectively) and these products were also approved by Health Canada in April. We recently announced our expanded R&D pipeline, including the disclosure of pembrolizumab (originator name Keytruda®) and nivolumab (originator name Opdivo®) biosimilars, marking our entry into the USD 62 billion global PD‑1 inhibitor market. These candidates have the potential to reduce treatment costs by 70–90%. In ophthalmology, our aflibercept (Yesafili®)
biosimilar will have a U.S. launch in the near term, representing growth in an over $8.75 billion space as of 2025, projected to reach $12.6 billion by 2032. In immunology, we continue to build our presence through our dominant biosimilar position for ustekinumab
(Yesintek®), approved by Health Canada last year. | | Leading the ‘Diabesity’ Market | With our newly integrated biosimilars and generics business, we are uniquely poised to lead in the combined diabetes and obesity, or ‘diabesity’, global epidemic, a crisis affecting more than 800 million people around the globe. As the world’s fourth-largest insulin supplier, Biocon has delivered more than 9.2 billion doses and is committed to serving one in five insulin-dependent patients worldwide. Its portfolio of regular, long-acting, and rapid-acting
insulins is backed by continued investment and early market entry, including U.S. FDA approval of the first interchangeable biosimilar insulin glargine in 2021 and insulin aspart in 2025. In the U.S., access to affordable insulin has too often remained out of reach for many people living with diabetes. Biocon’s nationwide, multi-year partnership with Civica, Inc. expands access to affordable insulin at a substantial reduction to prevailing market prices, so that people who need it don't have to choose between treatment and other essential needs.
Within this broader national framework, through CalRx, the State of California became the first U.S. state to directly contract for its own supply of affordable insulin. Importantly, Biocon is the only company operating globally with both biosimilar insulins and generic versions of complex peptides, including GLP-1s. Liraglutide (Biolide®) was launched in
select European countries and approved in the U.S. In late 2025, Biocon Limited signed an agreement with Ajanta to supply Semaglutide to three countries across Africa, Central Asia, and the Middle East. Combining the efforts of Biocon Limited and Biocon Biologics makes us
uniquely positioned in the growing diabesity market. | | An Environment Primed for Growth | The global biosimilars market is entering a new era of growth, driven by favorable
regulatory and policy developments. The FDA’s proposed guidance to eliminate the interchangeability distinction between biosimilars and interchangeable biosimilars is a watershed moment, simplifying the pathway for biosimilar adoption at the pharmacy level and accelerating access for patients. Separately, new FDA guidance on streamlining clinical pharmacokinetic testing could reduce development costs by $100 million to $300 million per product and cut timelines by up to 50 percent. Between 2025 and 2034, 118 biologics will lose patent protection, opening a $232
billion market and providing access to millions who would not have otherwise afforded needed medications. The Inflation Reduction Act and pending skinny label legislation could also unlock an additional $181 billion in projected savings over the next five years. | | Laying the Path for the Future | The integration of our generics and biosimilars businesses is more than a structural simplification. It is a bold statement about the future of healthcare. As patients and health systems worldwide seek greater affordability and broader access,
Biocon’s unified business model is designed to answer that call. Anchored in patient‑centric innovation and an unwavering commitment to affordability, we are well positioned to lead the next chapter of global healthcare, expanding access to high‑quality medicines and helping ensure that no patient is left behind. To learn more about Biocon's biosimilars and generics portfolio and its commitment to improving affordability and expanding patient
access worldwide, visit biocon.com. |
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