US President Donald Trump has recently signed an executive order aimed at lowering prescription drug prices, a move designed to tackle the significant price differences between innovator medications in the U.S. and those found in developed countries such as Europe and Australia. Kiran Mazumdar-Shaw, the executive chairperson of Biocon, emphasized that this order promotes the increased use of generics and biosimilars, areas where India excels. In a recent conversation, she shared her insights on the implications of this order for the pharmaceutical sector and Biocon’s performance and expansion plans in the U.S. market.

Impact of Trump’s Executive Order on Indian Pharma

President Trump’s recent initiative aims to bridge the pricing gap for innovator drugs between the U.S. and markets like Europe and Australia. The administration’s approach has shifted towards favoring price negotiations rather than imposing tariffs on imports. Notably, the executive order does not include generics or biosimilars, which already provide affordable alternatives under the Affordable Care Act. Indian firms like Biocon, known for their cost-effective and high-quality manufacturing, are uniquely positioned to take advantage of this shift. Set to take effect on April 15, 2025, the order encourages the development of generics and biosimilars, facilitating access to lower-cost imports and promoting their wider acceptance in the U.S.

Biocon’s Expansion Strategy in the U.S. Market

The U.S. market is crucial for Biocon’s growth trajectory. Currently, the company has successfully commercialized five biosimilars in the region. Among them, bTrastuzumab and bPegfilgrastim each command over 25% of the market share, while Insulin Glargine holds a mid-to-high teens share. Biocon is gearing up to launch bBevacizumab, branded as Jobevne, with an anticipated release in the latter half of 2026 for Yesafili (bAflibercept), a biosimilar to Eylea. Additionally, Biocon has partnered with Civica Inc, a nonprofit organization in the U.S., to enhance access to insulin. On the generics front, the company made significant strides by launching Lenalidomide and Dasatinib in the fourth quarter and receiving U.S. approvals for Everolimus tablets and Norepinephrine Bitartrate injection, broadening its specialty portfolio. Furthermore, Syngene, Biocon’s research services arm, has bolstered its manufacturing capabilities in the U.S. by acquiring a biologics facility, enhancing customer access and operational efficiency.

Strong Q4 Performance and Future Prospects

Biocon celebrated a robust finish to FY25, driven by solid performances across all business segments. The launch of Liraglutide in the U.K. marked a significant entry into the GLP-1 therapy segment. Four of Biocon’s biosimilars surpassed $200 million in sales, with the introduction of Yesintek (bUstekinumab) in the U.S., making it one of the first biosimilars to Stelara. Additionally, Syngene’s acquisition of a U.S. manufacturing facility further expands its biologics footprint. The fiscal year was characterized by consolidation, and the company is now poised for accelerated growth through innovation, digital transformation, and operational excellence.

Generics Business Sees Remarkable Recovery

Biocon’s generics segment experienced a remarkable rebound in the January-March period, marking its strongest quarter in FY25 with a 46% year-over-year and 53% sequential revenue growth. This turnaround was largely attributed to new product launches in the U.S., including Lenalidomide and Dasatinib. The introduction of Liraglutide in the U.K. for diabetes and weight management, alongside the launch of Tacrolimus in China, and approvals for Liraglutide in the EU and Everolimus tablets in the U.S. all contributed to this success, setting the stage for future growth.

Biosimilars Segment Growth and Market Positioning

The biosimilars division of Biocon recorded a 9% year-over-year revenue increase in the latest quarter, buoyed by market share gains in the U.S. and successful tender wins in emerging markets. Fulphila and Ogivri now boast U.S. market shares of 30% and 26%, respectively, double compared to the previous year. The launch of Yesintek in the U.S. has gained traction, already being available in Germany and poised to benefit over 100 million lives. Biocon’s emerging markets business has also performed exceptionally well, thanks to successful tenders for bBevacizumab and rh-Insulin. Overall, the biosimilars sector saw a 15% year-over-year growth, attributed to the advantages gained from the acquisition of Viatris.

Looking Ahead: Biocon’s Growth Trajectory

Biocon is set on a promising growth path, having established a solid foundation through successful product launches, regulatory achievements, and capacity expansions. Focused on execution and deepening its market presence in the U.S. and emerging markets, Biocon aims to drive further innovation and affordability. The next phase of its strategy revolves around scaling up its pipeline and exploring new opportunities in the biosimilars and specialty generics arenas worldwide.