LUGPA Policy Brief: Expanding Access to Lower-Cost Biosimilar Drugs

November 2025

Biosimilars are biologic medical products that are highly similar to FDA-approved biologics and have no clinically meaningful differences in safety, purity, or potency. Often described as the “generic version” of biologics, biosimilars can lower costs while maintaining the same therapeutic effectiveness. They are used to treat serious conditions such as cancer, autoimmune diseases, and rare disorders.

Biologic drugs represent just 5% of prescriptions but account for over half of U.S. drug spending. Annual treatment costs can reach hundreds of thousands of dollars, creating major affordability barriers for patients and adding strain to healthcare systems.

High costs have led many patients to ration medications or abandon treatment, resulting in poorer outcomes and higher hospitalizations. Even insured patients often face significant out-of-pocket expenses due to coverage gaps and high deductibles. Despite strong safety data, biosimilar adoption remains slow due to provider hesitancy, patient uncertainty, and persistent misinformation.

Since the first U.S. biosimilar approval in 2015, the FDA has authorized 76 biosimilars, compared to over 110 approved by the European Medicines Agency. Biosimilars account for less than 20% of U.S. biologic use. Only 10% of biologics currently have biosimilars in development, and more than a quarter of high-value biologics (over $500 million in annual sales) have none.

Biosimilars are becoming increasingly important in urology by improving access to advanced biologic therapies and reducing costs for patients and practices. Recently, the FDA approved several denosumab biosimilars—such as Jubbonti, Wyost, and Bilprevda—for increasing bone mass in men with prostate cancer undergoing androgen deprivation therapy. These biosimilars, which inhibit bone breakdown, offer a less expensive alternative to the original denosumab products. Urology practices are eligible to administer these drugs but must carefully navigate economic and reimbursement considerations to integrate them effectively into patient care.

Barriers to Market Entry

Developing a biosimilar is costly and time-consuming—comparative efficacy studies can take up to three years and cost an average of $24 million, even when advanced analytical testing may be sufficient.

Key barriers include:

• Regulatory complexity: Early frameworks have not kept pace with scientific advances.
• Low market adoption: Uncertain financial returns discourage investment.
• Limited substitution authority: Pharmacists can only substitute “interchangeable” biosimilars, restricting access.

Economic Impact

Since 2015, biosimilars have generated $56 billion in healthcare savings, including $20 billion in 2024. They typically launch at 50% lower prices than brand-name biologics, providing immediate relief to patients and programs like Medicare and Medicaid.

Recent FDA Efforts

The FDA has advanced several reforms to accelerate biosimilar access:

• Streamlined approvals: Increasing reliance on advanced analytical testing instead of redundant clinical trials.
• Expanded substitution: Easing interchangeability policies to allow pharmacy-level substitution.
• Reduced red tape: Clarifying regulatory pathways and lowering development uncertainty.

2025 Legislative and Regulatory Updates

FDA Draft Guidance (October 29, 2025)
The FDA’s new draft guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,” proposes reducing reliance on costly comparative clinical efficacy studies and emphasizes analytical testing as a more efficient alternative. It also simplifies interchangeability designations, potentially cutting biosimilar development time in half and lowering costs significantly.

Expedited Access to Biosimilars Act (S.1414)
Introduced by Sen. Rand Paul in April 2025, this bill would expedite approvals by removing mandatory requirements for certain clinical studies unless specifically justified by the HHS Secretary. It maintains key pharmacokinetic and safety requirements and has been referred to the Senate HELP Committee.

Biosimilar Red Tape Elimination Act (S.1954/H.R.5526)
Introduced by Sen. Mike Lee and Rep. August Pfluger, this bipartisan bill would eliminate the distinction between biosimilars and interchangeable biosimilars, automatically granting interchangeability to all FDA-approved biosimilars. Supporters, including the Association for Accessible Medicines and the Biosimilars Council, say it would enhance competition and reduce costs, though some physician groups have raised safety and step therapy concerns. Both bills remain in committee as of October 2025.

State Developments

• New York S3485A expands insurance formulary coverage for interchangeable biosimilars.
• Assembly Bill A500 creates a state generic and biosimilar manufacturing facility.
• A 2025 Avalere Health report highlights wide state variation in substitution laws, creating uneven access nationwide.

FDA officials have warned of a potential “biosimilar void,” as 118 biologics will lose patent protection between 2025 and 2034—highlighting the need to accelerate development.

LUGPA supports policies that promote innovation, transparency, and affordability in specialty drug markets while maintaining rigorous safety standards. Reducing unnecessary regulatory barriers will expand patient access to advanced therapies, strengthen competition, and sustain independent physician practices.