Imagine a future where life-changing medicines are affordable and accessible to everyone. At Biocon Biologics, we’re working to make that future a reality through our commitment to biosimilars—cost-effective alternatives to expensive biologic drugs. Biosimilars offer the same safety and effectiveness as their reference products, but at a fraction of the cost, helping patients and healthcare systems save billions.  

In the U.S., biologic medicines account for only about 3 percent of prescriptions but drive roughly 46 percent of total drug spending, putting significant strain on patients and the health care system, according to reporting by the Center for Biosimilars. Biosimilars help close this gap by delivering the same high standards of safety and effectiveness at 15–35% lower cost, creating the potential for billions in savings each year for Medicare beneficiaries and millions of Americans who rely on biologic treatments. 

Driving Change Through Advocacy 

Biocon Biologics is at the forefront of biosimilar advocacy in North America. Our team is actively engaging with policymakers, regulators, and industry partners to advance legislation and regulatory reforms that make biosimilars more accessible. Through strategic partnerships and direct engagement, we’re shaping the future of healthcare.

Key Policy Wins 

Our leadership is making a difference. Matt Erick, Chief Commercial Officer for Advanced Markets at Biocon Biologics, serves on the board of the Association for Accessible Medicines (AAM). AAM works to expand access to safe, quality, and effective medicines, ensuring more generic and biosimilar treatments reach the people who need them. By engaging directly in AAM, industry leaders help drive collective advocacy, shape biosimilar-friendly policy, and champion patient affordability. Together with AAM, we’ve helped secure major policy advancements in the U.S.: 

• Biosimilars Interchangeability Legislation: The introduction of the House version of the Biosimilar Red Tape Elimination Act marks a significant step toward reducing barriers for biosimilars, despite strong opposition from industry groups.  

• FDA Guidance: In October 2025, the U.S. FDA announced draft guidance to streamline biosimilar development, allowing companies to conduct fewer studies while maintaining safety and efficacy standards. This change will accelerate approvals and reduce development costs—a win for patients and sustainable healthcare.  

“We welcome the U.S. FDA’s initiative to streamline biosimilar development and ease market entry barriers. This progressive step will accelerate patient access to safe, effective, and affordable biologic therapies for cancer, diabetes, and other chronic diseases, while also helping reduce development costs. At Biocon Biologics, we remain committed to advancing global biosimilar access by partnering with healthcare systems worldwide to deliver cost-effective biologic medicines that enhance patient outcomes.”

– Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. 

Advocacy in Action 

In September, the Biosimilars Forum held an Executive Fly-In, bringing together industry leaders, policymakers and patient advocates on Capitol Hill. According to the Association for Accessible Medicines’ 2025 savings report, biosimilars have generated $56.2 billion in savings over the past decade, with the potential to reach $181 billion as adoption expands. And the Biosimilars Council reports that of the 118 biologics expected to lose patent protection in the next decade; only about 10 percent have biosimilars in development, underscoring the need for continued advocacy. Josh Salsi, head of North America at Biocon Biologics, joined the event to highlight these challenges and opportunities. 

Matt Erick and Kimberly Maxfield at The Atlantic’s “The Next Frontier for Accessible Medicines” event.

Thought Leadership and Industry Engagement 

Biocon Biologics is proud to participate in key industry events. In October, Matt Erick spoke at The Atlantic’s “The Next Frontier for Accessible Medicines,” discussing how a “Biosimilars First” approach can help to unlock affordable access for patients. Kimberly Maxfield, PhD, Head of U.S. Regulatory Affairs, Biocon Biologics, also participated in The Atlantic’s event, speaking on the “Building a Sustainable Pipeline: Accelerating Biosimilar Development,” panel.

Our company was also well represented at the GRx+Biosims 2025 conference in Bethesda, MD. Attendees included Arlene Wolny, Global Head of Regulatory Affairs; Dr. Elena Wolff-Holz, VP and Global Head of Clinical Development; Anita Krishnan, AVP and Head of Analytical Sciences; Matte Wilhelm, Head of North America Strategy & Operations; and Kimberly Maxfield. These leaders shared insights and helped drive industry dialogue.

Looking Ahead 

At Biocon Biologics, we are pursuing our ambition to deliver affordable, lifesaving medicines to patients around the world. This purpose drives every aspect of our work, from advocacy to innovation, ensuring that our efforts have a meaningful impact on patients’ lives.

As legislative and policy initiatives move forward, Biocon Biologics will continue to strengthen market access and support the broader goal of expanding healthcare affordability.