Biosimilars could lead to over $54 billion in savings over the next ten years, giving 1.2 million patients access to needed medicines and increasing the quality of life for those patients. The Biosimilars Council has identified the issues that stand in the way of access to these medicines, and, by working with federal lawmakers, the FDA, and other stakeholders, we advocate for finding solutions to these issues.
By increasing our share of voice in today’s biosimilars narrative, and advocating for issues that can create incentives for increased biosimilars development and adoption, millions of Americans can experience healthier lives.
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Read on for our priority issues.
Biosimilars, like all biologic drugs, have an international nonproprietary name (INN). Each biosimilar shares this INN with a reference product. Recently, the FDA has determined that biosimilars require the addition of a random, four-letter suffix to identify them as different than their reference product counterpart. It is the position of the Council and numerous other stakeholders, including pharmacists, health plans, pharmacy benefit managers and consumer groups that the addition of a suffix could lead to patient an prescriber confusion and increase the possibility of medication errors and effectively separate the biosimilar from existing safety information about the underlying molecule. The Biosimilars Council is committed to working with regulators to create a naming policy that encourages biosimilars access and adoption for patients.
Interchangeable biosimilars are products that are approved as interchangeable with a reference product for a patient to switch between. Interchangeable biosimilars are as safe and as effective as a biosimilar or reference product and both physicians and patients should have confidence in using interchangeable biosimilars. Recently the FDA finalized guidance to determine how biosimilars may achieve an interchangeable designation. The Biosimilars Council is committed to educating stakeholders on the safety and efficacy of biosimilars and interchangeable biosimilars.
Biosimilar developers must combat several obstacles in bringing a product to market. Brand companies often create such obstacles such as hurdles intended to thwart competition. These hurdles and activities, such as patent abuses and trade agreement provisions that extend monopolies for reference products, limit the ability of biosimilars to reach the market in a timely manner, ultimately hurting patients. The Biosimilars Council is committed to working with regulators to create policies that fairly encourage and protect innovation while ensuring all patients have access to the treatment options they need.
Biosimilars are safe and effective medicines for patients. They are subject to rigorous FDA review and approval and are regulated after market entry just like 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 but 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.
The FDA carefully regulates biologic development, 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, however many aspects of biosimilars development remain undetermined. 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.
America’s trade policy should reflect U.S. law and promote a balance between supporting the development of innovative medicines and promoting competition through greater access to generic and biosimilar medicines. Trade policy in the U.S. should incentivize generic and biosimilar market access in the United States and in foreign markets and encourage patent and exclusivity policies that meet the needs of each trading partner.