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Biocon Biologics  /  Our Business  /  Global Biosimilars Portfolio

GLOBAL BIOSIMILARS PORTFOLIO

Biocon Biologics has one of the deepest portfolios of biosimilars in the industry, spanning across insulin, monoclonal antibodies and recombinant proteins. Our long-term investments in R&D have yielded several molecules in diabetes, oncology, and immunology of which five have been already commercialized in markets globally.

The biosimilars that we are developing will address a USD 70 billion global market opportunity by FY27.

Deepest portfolios of biosimilars

Biocon Biologics has achieved many global ‘firsts’ and set new benchmarks for the global biosimilars industry. In July 2021, we were the first to get an interchangeable designation for our biosimilar Insulin Glargine (Semglee) from the U.S. FDA. This is a testament to the Company’s scientific excellence and robust quality comparability data.

Committed to Making Insulins Available & Accessible

*Co-developed with Viatris.

We were also the first company to receive U.S. FDA approvals for biosimilar Trastuzumab in 2017 and biosimilar Pegfilgrastim in 2018.

The commercial success of our biosimilar versions of Pegfilgrastim, Trastuzumab and Insulin Glargine and in-licensed biosimilars, Adalimumab and Etanercept has allowed us to continue to invest in our pipeline.

Launches of biosimilars of Bevacizumab, Aspart and Adalimumab, especially in the U.S., are expected to contribute to the near-term growth of the business.

We have built a sizeable portfolio of unpartnered biosimilars that are at various stages of development. We are developing various presentations of recombinant human insulins (rHI) for the U.S. Our biosimilar referencing Eli Lilly’s Humulin-R, a short-acting rHI, demonstrated equivalence in a pharmacokinetic (PK) and pharmacodynamic (PD) study published in the journal, ‘Diabetes, Obesity and Metabolism’, in January 2022.

We have also advanced biosimilar Ustekinumab and biosimilar Denosumab into clinical development.

As a part of the Viatris deal, Biocon Biologics has exercised the option to acquire Viatris’ rights for its biosimilar Aflibercept asset, a proposed biosimilar to Regeneron’s Eylea, which is indicated for use in multiple ophthalmology indications. Viatris has been the ‘first to file’ for a biosimilar Aflibercept in the U.S.

Our portfolio also includes biosimilar Pertuzumab, biosimilar Insulin Glargine 300U and seven other early stage undisclosed programs, which would sustain our growth in the long-term.

Even as we have continued to strengthen our biosimilars portfolio to broaden access to patients, our investments so far have focused on debilitating non-communicable diseases.

The COVID-19 pandemic and the ensuing crisis exposed the inequity in access to global health, particularly when combating communicable diseases. Biocon Biologics has demonstrated scientific credibility, global-scale manufacturing and a proven track record of commercial success across geographies. Our strategy of “Expanding on Adjacencies” is about leveraging our strengths to invest in growth drivers for the future.

The strategic alliance with Serum Institute Life Sciences (SILS) is an important step in that direction as we expand into developing vaccines as a potential future growth driver. The ‘asset-light’ deal structure of this alliance with the world’s largest vaccine maker has ensured that Biocon Biologics has access to assured vaccine manufacturing capacity for the next 15 years.

Upon closing of the transaction, Biocon Biologics will get committed access to a 100 million doses of vaccines annually for ~15 years along with commercialization rights to the entire vaccines portfolio of SILS.

A Century of Insulins

Marking 100 years of the pivotal medical breakthrough that is saving millions of people with diabetes.

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