Supreme Court Hears Biosimilars Patent Case

Monday May 8, 2017

The country has undergone a great deal of change from December to today – but one thing that has not changed is that Americans want action to bring down the price of prescription drugs. A recent Kaiser Health Tracking Poll showed that over 60% of Americans believe lowering the cost of prescription drugs is one of the top health priorities for the country. This need for action transcends party lines and has been consistent in polling over the last several months.

Nearly every day, there’s a headline about skyrocketing prescription drug costs and the impact these costs have on patients and families. Many of the most expensive medicines on the market are biologic drugs, which are the most rapidly growing segment of brand prescription drug costs in the U.S. — more than $100 billion is spent on them each year. Biosimilars are highly similar or interchangeable versions of biologic drugs. As we’ve seen in Europe for many years, biosimilars help drive down the price of biologic drugs and help increase patient access to important, life-saving medicines. But brand biologic manufacturers are doing their best to keep biosimilars off the U.S. market.

Last week, the Supreme Court heard arguments in Amgen v. Sandoz, a case that could either help ease the burden on patients and payors by providing more timely access to biosimilars, or further protect brand-name drug companies from biosimilar competition at the continued expense of those paying the bills, including federal insurance programs.

Branded drug companies, which were given a 12-year exclusivity period before biosimilar competition under the Biologics Price Competition and Innovation Act (BPCIA) of 2010, are now unfairly trying to mandate a legal maze of litigation to delay competition even more, by adding six more months of monopoly protection from competition. A recent article by the Associated Press and an op-ed in today’s edition of Morning Consult highlight the potential impact of the Court’s decision:

  • Delaying access for an additional six months will ensure maximum profits for brand drug manufacturers and deny patients access to more affordable alternatives like biosimilars.
  • Giving brand drug manufacturers a bonus six months of monopoly pricing will cost the public billions of dollars.
  • Putting profits ahead of patient access will deprive the U.S. health care system of already scarce funds to find new cures.

The Court’s final decision is expected in June; both the Biosimilars Council and the Association for Accessible Medicines urge the Supreme Court to recognize the importance of biosimilar medicines in promoting patient access to affordable health care.

For more information, please review our recent press release and amicus brief on the case.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at

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