LUGPA Policy Brief: The Importance of Biosimilar Drugs

Sept. 2024 

Biosimilar drugs offer significant benefits to patients, providers, and the healthcare system. These biologic medicines are highly similar versions of already FDA-approved biologic drugs (reference products) with no clinically meaningful differences in safety, purity, and potency. They enhance treatment options, improve patient access to affordable therapies, and foster competition in the pharmaceutical market.

Benefits to Patients and Providers

Increased Access and Affordability: Biosimilars can provide more affordable treatment options compared to their reference biologics, which is crucial for patients facing high out-of-pocket costs or limited access to necessary medications.

Enhanced Treatment Options: By expanding the range of available therapies, biosimilars enable healthcare providers to tailor treatments more precisely to individual patient needs, leading to improved patient outcomes and better disease management.

Promotion of Competition: Introducing biosimilars into the market can stimulate competition, driving down costs and encouraging innovation among manufacturers. This competitive environment benefits both patients and providers by promoting cost-effective healthcare solutions.

Support for Healthcare Sustainability: As healthcare costs continue to rise, biosimilars present an opportunity to mitigate spending without compromising the quality of care, making them a valuable tool in achieving sustainable healthcare delivery.

Reforms Needed to Expand Availability

Despite their promise, several challenges hinder the widespread adoption of biosimilars:

Education and Awareness: Many healthcare providers and patients lack sufficient knowledge about biosimilars, leading to hesitancy in prescribing and using these therapies. Increased education efforts are crucial to foster trust and acceptance.

Regulatory Barriers: Streamlining the regulatory approval process for biosimilars can accelerate market entry and expand availability. Simplifying interchangeability guidelines and addressing patent-related hurdles are essential steps in facilitating quicker access to these therapies.

Market Access Policies: Implementing policies that incentivize the uptake of biosimilars, such as reimbursement mechanisms reflecting their cost-saving potential, is necessary to encourage providers and healthcare systems to adopt these drugs.

Legislation to Expand Coverage

Several legislative efforts are underway to bolster biosimilar accessibility and utilization:

Increasing Access to Biosimilars Act (H.R. 1352, S. 3934)

Purpose: Boost competition and increase incentives for providers to prescribe biosimilars over more expensive reference agents.

Provisions: A 3-year demonstration project to assess whether offering a special payment can encourage doctors to prescribe more biosimilars for Medicare beneficiaries. Participating doctors will receive extra payments for prescribing biosimilars instead of originators without increasing out-of-pocket costs for patients. After three years, the HHS Secretary will report to Congress on the project's effectiveness.

The Preserving Access to Affordable Generics and Biosimilars Act (S. 142)

Purpose: Limit anticompetitive “pay-for-delay deals” that prevent or delay the introduction of affordable follow-on or generic versions of branded pharmaceuticals.

Provisions: Addresses pay-for-delay deals affecting biosimilar and interchangeable biologics in addition to generic drugs.

Stop STALLING Act (S. 148)

Purpose: Make it an unfair method of competition to submit an objectively baseless petition to the FDA in an attempt to interfere with a competitor's application for market approval of a drug.

Provisions: Authorizes the Federal Trade Commission to sue individuals or entities that submit such petitions. A party found liable shall be subject to civil penalties, including fines of up to $50,000 for each day the FDA spent reviewing the baseless petition.

Biosimilar drugs represent a pivotal opportunity to transform healthcare delivery by increasing access, reducing costs, and promoting treatment innovation. Addressing current regulatory and legislative challenges is essential to realizing the full potential of biosimilars and ensuring that patients and providers can benefit from these transformative therapies. By advocating for reforms and supporting legislation that expands biosimilar coverage, policymakers can advance patient-centered care and foster a more sustainable healthcare system.