Biocon Ltd has announced that its subsidiary, Biocon Biologics Ltd, will add three oncology biosimilars to its pipeline as part of a planned expansion of its cancer treatment portfolio. The company will present these developments at the 44th Annual JP Morgan Healthcare Conference in San Francisco in January 2026, according to a regulatory filing and company disclosures.
The biosimilars under development include versions of Trastuzumab combined with Hyaluronidase, aligned with Roche’s Herceptin SC/Herceptin HYLECTA, as well as Nivolumab and Pembrolizumab, which reference Opdivo and Keytruda, respectively. Nivolumab and pembrolizumab are immune checkpoint inhibitors targeting the PD-1 pathway and are widely used across multiple cancer indications, while the trastuzumab/hyaluronidase formulation is primarily used in specific breast cancer treatment settings.
These assets are among high-value oncology biologics expected to face patent expiry over the next five years, opening pathways for biosimilar competition. In 2024, global sales of pembrolizumab were estimated at approximately $29.5 billion, while nivolumab generated about $9.3 billion in revenue. Sales of Herceptin SC and Herceptin HYLECTA together stood at roughly $1.72 billion, highlighting the commercial scale of the reference products.
With the inclusion of these three candidates, Biocon Biologics’ oncology portfolio will extend beyond its current range of 17 oncology therapies. The existing portfolio includes biosimilars and small-molecule cancer drugs, including pertuzumab (Perjeta), which has recently been submitted to the US Food and Drug Administration for regulatory review.
The expanded oncology pipeline forms part of Biocon Biologics’ broader strategic roadmap, which includes plans to become a wholly owned subsidiary of Biocon Ltd by March 31, 2026. The proposed integration is intended to enhance operational efficiency and consolidate capabilities across biosimilars and complex generics, spanning therapeutic areas such as diabetes, oncology, and immunology.
The company’s emphasis on oncology biosimilars reflects wider industry dynamics, as multiple blockbuster biologic cancer therapies approach loss of exclusivity. By developing biosimilar alternatives to high-demand oncology drugs, Biocon Biologics aims to improve patient access to more affordable treatments while strengthening its position in the global biosimilars market, which is valued in the tens of billions of dollars.
