Advocacy
Working for Patients and Families Who Rely on Biosimilars
Since the first biosimilar launch in 2015, patients and the healthcare system have saved nearly $36 billion. Additionally, biosimilars have been used in almost three billion days of patient therapy.
However, regulatory and market barriers to entry are slowing biosimilar uptake. This means millions of patients are missing out on the incredible benefits of biosimilar medicines.
The Biosimilars Council works directly with key officials – inside and outside of Washington, DC – to craft policies that boost biosimilar uptake and generate substantial financial savings for patients. Scroll to learn more about our current issues of focus.
“Biosimilars hold the key to ensuring affordable access to biologic-alternatives medicines for all consumers. We exist to educate, advocate, and promote the development of these products.”
– Biosimilars Council Executive Director,
Craig Burton
Biosimilar Advocacy Issues
Sustainability & Patient Access
Biosimilars have a proven ability to compete with brand name biologics, providing patients with more options for their care and lowering drug prices. Despite patients’ reliance on these vital medicines, biosimilars face significant challenges that threaten patients’ access to care and billions in savings for them and their families.
The Biosimilars Council advocates for policies that ensure patients have access to biosimilars, no matter their insurance carrier, by putting an end to brand rebate traps and reforming providers to incentivize the use of lower-cost biosimilars.
Legislative Priorities
Biosimilars Development & Streamlining
Biosimilar and brand-name biologic products manufacturing is different from manufacturing small molecule drugs, like generics.
The FDA carefully regulates the development of biologic products, including biosimilars. Biosimilars have been approved for use in the United States since the passage of the BPCIA as part of the Affordable Care Act, and since then the development and manufacturing of biosimilars have continued to advance.
The Biosimilars Council is committed to working with regulators including the FDA, CMS and other stakeholders to create streamlined policies for biosimilar approval and development for the benefit of patients.
Interchangeability
An interchangeability designation is a unique form of regulatory review used in the United States and is not an indication of superior quality.
There’s a lot of misinformation out there about interchangeable biologics. This fact sheet answers frequently asked questions about biosimilars and their Interchangeability with other biologic medications.
Misinformation
FDA-approved biosimilars have no clinically meaningful difference from the brand name product upon which they are based. However, brand-name manufacturers have tried to confuse patients about biosimilars’ uses and benefits.
Biosimilars are safe and effective medicines for patients. They are subject to rigorous FDA review to assure safe and effective use for patients. Biosimilars are regulated after market entry in the same fashion and with the same rigor as reference biologics. Despite these facts, there is a targeted effort by brand companies to disseminate false information on the safety and efficacy of biosimilars. Such efforts threaten biosimilars adoption and hurt the health care system, while limiting patient access to needed treatments.
The Biosimilars Council is focused on working with regulators to combat such misinformation campaigns to ensure patient access to biosimilars.
Patent Abuse
Patent thickets are an anticompetitive practice used to prevent or delay the launch of biosimilars, increasing costs for patients and reducing their options for care.
Biosimilar developers must combat several obstacles in bringing a product to market. Brand companies often create obstacles intended to thwart competition, such as patent abuses and trade agreement provisions that extend monopolies for reference products and limit the ability of biosimilars to reach the market in a timely manner, which ultimately hurts patients.
The Biosimilars Council is committed to working with policy makers to encourage and protect innovation and competition to ensure patients have access to the treatment options they need.
The Biosimilars Council applauds the Senate passage of the Cornyn-Blumenthal Patent Thicket Legislation, which is aimed at reforming patent abuse in the pharmaceutical industry.
Biosimilars Council Applauds Senate Passage of Cornyn-Blumenthal Patent Thicket Legislation
The Biosimilars Council recently held a Capitol Hill briefing detailing the way brand-name pharmaceutical companies abuse the patent system and how Congress can fix the problem.
State Issues
State lawmakers can take meaningful action to lower prescription drug costs and increase patient access to biosimilars.
The availability of safe, effective, and affordable biosimilars means savings for a state’s residents and taxpayers. However, adoption of biosimilars at the state level is affected by education and misinformation, provider incentives, and health plan and pharmacy benefit manager (PBM) formulary decisions. The Biosimilars Council state policy team educates legislators in every state on the value that biosimilars represent – and how to protect those savings.
Eliminate Threats to Coverage of Lower-Cost Biosimilar Medicines at the State Level
Ensure Coverage & Promote Use of Cost-Effective Biosimilar Medicines at the State Level