A Watershed Year for Biosimilars in the U.S.

Tuesday December 19, 2017

For anyone following the nascent biosimilars market in the U.S., 2017 has been a busy year: the Centers for Medicare & Medicaid Services (CMS) revised its biosimilars reimbursement policy in Medicare Part B to provide each non-interchangeable biosimilar with a unique billing code and payment rate; the U.S. Supreme Court unanimously ruled to accelerate patient access to biosimilar medicines; and the World Health Organization (WHO) decided to put the International Non-Proprietary Name (INN) Biologic Qualifier (BQ) naming convention on hold.

As we close out the year, we have collected articles that highlight key issues facing biosimilars and why 2017 was a watershed year for biosimilars in the U.S.:

[carousel_anything thumbnails=”arrow” arrows_offset=”-40″ arrows_alignment=”75″ arrows_size=”50″ arrows_color=”#24db13″ arrows_active_color=”#ffffff”]

Best asset to fight rising drug prices: Enhance generic competition

Increasing access to generic and biosimilar medicines will strengthen our nation’s economy while improving patients’ access to the medicines on which they rely.

Read Article

In Amgen-Sandoz SCOTUS case, biosim makers lambaste ruling’s 6-month exclusivity gift

In a 49-page brief (PDF) filed with the Supreme Court, the Biosimilars Council took issue with the U.S. Federal Circuit’s ruling that would give branded drugmakers an additional six-month reprieve before a biosimilars launch.

The Next Drugs: The Future for Biosimilars An Atlantic Policy Briefing

Watch the full video of The Atlantic event, which gathered key stakeholders to examine the future for biosimilars domestically and abroad.

New drugs could save the US billions of dollars — but there’s something holding them back

Having more biosimilars in the US would be a big deal: It might be the best way to drive down the cost of biologic medications that have been around for a while. The savings of putting people on far less costly biosimilars — even just new patients who have never taken the original — are estimated to be billions of dollars.

Biosimilars Can Bend the Drug Cost Curve, but Only If Patients Have Access

Biosimilars offer the potential for tens of billions of dollars in patient, insurer and health system savings, but only if patients can access them in a timely manner — as Congress directed.

Supreme Court Ruling Raises Biosimilars’ Access

The Supreme Court’s decision today is a huge victory for American patients and consumers,” said Chip Davis, President and CEO of the Association for Accessible Medicines (AAM). “This ruling will help provide faster access to lower-cost biosimilar medicines for millions of patients facing diseases such as several forms of cancer, rheumatoid arthritis, psoriasis, multiple sclerosis, and other life-threatening conditions.

Biosimilars Gain Widespread Adoption by Health Plans

New research from Avalere found that most health plans are covering at least one of the two biosimilar products currently on the market.

Take the Generic Drug, Patients Are Told — Unless Insurers Say No

Faced with competition, some pharmaceutical companies are cutting deals with insurance companies to favor their brand-name products over cheaper generics. Insurers pay less, but sometimes consumers pay more.

This Shield of Patents Protects the World’s Best-Selling Drug

Over Humira’s lifetime, AbbVie has secured more than 100 patents to prevent anyone from attempting to copy the biologic, with $16 billion in annual sales.

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

The US Biosimilars Council praised the WHO move, which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a four-letter suffix to distinguish them from their reference products, which is similar to what WHO had proposed.

Common Ground on Biosimilar Coding

The Biosimilars Council, which represents biosimilar makers, praised the CMS decision, citing an analysis that separate codes would save the federal government $11.4 billion over the next ten years.

How to Reduce Medical Drug Prices at a Stroke

PhRMA is fighting the use of biosimilars using the same tools they used to fight generics in the 1980s – legal challenges and dissemination of clinical misinformation.  And just like generics, switching to biosimilar drugs is the one of the most effective ways to reduce overall drug costs.


For more information, visit the Biosimilars Council website.

The Biosimilars Council is on TwitterFacebook and LinkedIn. Follow us for the latest updates on biosimilars.

Join us at an upcoming AAM meeting:

ACCESS! 2018 AAM Annual Meeting
February 12-14, 2018
Orlando, FL

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 www.accesiblemeds.org.

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.


Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:



October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.