Access and affordability are at the heart of today’s U.S. healthcare conversation, and that isn’t likely to change any time soon. As costs continue to rise and disparities in access persist, conversation is increasingly turning toward biosimilars. Biosimilars offer the potential to expand access to life-saving treatments while easing the financial burden on patients, providers, and payers alike.
The State of Biosimilars in the United States
Biosimilars are at a crossroads in the United States. After years of incremental progress, biosimilars are delivering on their promise to transform patient access and drive down costs. The numbers support this. Recent years have witnessed significant cost savings and increased competition in the biologics market due to biosimilar entry. According to industry analyses, biosimilars have accounted for an estimated $56 billion in savings since 2015, with a notable acceleration in adoption and impact over the past two years.
Several factors are driving this momentum, including evolving policy and regulatory environments. Just recently, the FDA announced additional plans to streamline testing when scientifically justified. The guidance will remove earlier recommendations that require at least one clinical pharmacokinetic (PK) study and will instead allow PK studies to use a reference drug approved outside the U.S. This move will reduce unnecessary PK testing and accelerate patient access to safe, effective, and affordable biologic therapies for cancer, diabetes, and other chronic diseases, while also helping reduce development costs, which will pass on to the consumer through lower drug costs.
The FDA has also proposed guidance that could streamline the development process by, in some cases, reducing or eliminating requirements for extensive clinical trials when sufficient analytical and functional data are available. This could lower barriers to entry for new biosimilars and potentially speed up access for patients. Additionally, federal and state reforms, including the Inflation Reduction Act and “skinny label” legislation, are poised to remove legal and reimbursement obstacles, unlocking an estimated $181 billion in savings over the next five years.
The impact of this inflection point is being felt across the healthcare ecosystem. For patients, increased availability of biosimilars means greater access to advanced treatments that may have previously been cost-prohibitive. For providers, it offers a broader toolkit of therapeutic options without sacrificing efficacy or safety. For payers (including both public and private insurers), biosimilars present an opportunity to both manage rising drug costs and improve access, while maintaining high-level patient outcomes.
In the United States, chronic conditions such as diabetes and cancer continue to drive healthcare costs and present challenges in access to treatment. For instance, the total annual cost of diabetes in the United States was over $410 billion in 2022 and national cancer costs are expected to increase to $246 billion by 2030. Biosimilar insulins and oncology medicines are two areas where expanded uptake could have a substantial impact. Initiatives at both the state and federal level, as well as public-private partnerships, are exploring how biosimilars can be leveraged to improve the affordability and availability of essential therapies. For example, efforts to cap insulin prices in certain states are making a tangible difference for people who rely on this essential medication. Biocon Biologics’ recent agreement with Civica to manufacture and supply Insulin Glargine medicine under the CalRx brand in California is the kind of collaboration that will hasten accessibility and affordability. This means patients will be able to access the medications they need for only $11 per pen.
Biosimilars’ Impact
The growing role of biosimilars is not just about short-term cost savings. It reflects a broader shift toward more sustainable healthcare systems that balance innovation with affordability. As more biologics lose patent protection, with 118 biologics expected to lose exclusivity between 2025 and 2035, amounting to $234 billion overall, and more biosimilars become available in therapeutic areas such as oncology, immunology, and ophthalmology, the potential for impact expands even further. However, only about 10% of those biologics have biosimilars currently in development. That means the vast majority – 90% – of biologics on the market today still lack a lower-cost alternative to the reference drug, underscoring the missed opportunity for savings.
Education is a critical ingredient for success. Many patients and even some providers remain unfamiliar with biosimilars or have questions about their safety and efficacy. Addressing these gaps through transparent communication and stakeholder education is essential to building trust and ensuring that the benefits of biosimilars reach those who need them most.
The next decade will see biosimilars become the standard of care across many disease areas, helping to ensure that advances in medicine translate into tangible benefits for all segments of society.
Taking Action
At our company, we are acting on this momentum and making deliberate choices to leverage our resources to meet the world’s most pressing needs.
We are actively engaging with policymakers, regulators, and industry partners to advance legislation and regulatory reforms that make biosimilars more accessible. Matt Erick, Chief Commercial Officer, serves on the board of the Association for Accessible Medicines (AAM). 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., including the introduction of the House Biosimilars Red Tape Elimination Act. Through strategic partnerships and direct engagement, we’re shaping the future of healthcare.
We are setting the example for other organizations working in the industry, leading the charge for a more biosimilar and generics-friendly environment.
Enacting Change
Biosimilars have the power to turn access and affordability from distant hopes into everyday realities, especially for patients who have long waited for effective treatment options. For too many, the world’s most advanced and effective biologic therapies remain out of reach due to cost.
This inflection point is not only a milestone for the biosimilars industry, but a pivotal opportunity to open doors for those in need, ensuring that breakthroughs in medicine reach every patient, not just a fortunate few.
We are making moves for the future. It is time for others to do the same. By embracing this moment, we take a crucial step toward a more equitable, sustainable, and compassionate future in healthcare.
Shreehas Tambe
Shreehas Tambe is the CEO & Managing Director of the combined generics and biosimilars business at Biocon Limited. Across nearly three decades with Biocon, Shreehas has held several leadership roles, playing a pivotal part in scaling multiple businesses globally and advancing science-led access to lifechanging medicines for patients worldwide. During his tenure as the CEO & Managing Director of Biocon Biologics, the company has become one of the world’s Top 5 biosimilar companies by revenue with a valuation of USD 5.5 billion in 2025. He led the transformational acquisition of Viatris’ biosimilars business and oversaw its rapid consolidation, creating a fully integrated, lab-to-patient, global biologics enterprise.
