Biosimilars Bulletin | January 2020

Tuesday February 11, 2020

Each month, the Biosimilars Council sends a newsletter with the latest updates in the biosimilars industry including policy movement, educational resources and upcoming events. To stay current on biosimilars, sign-up to receive these monthly updates on the form to the right.

News and Updates

AAM and its Biosimilars Council Applauds House Passage of the CREATES Act

We applaud the passage of the CREATES Act, which will lower drug prices for patients through increased competition and by stopping the abuse of FDA’s safety programs and non-FDA mandated closed distribution systems.

Giveaway to Brand Manufacturers in End of Year Spending Bill

Groups that advocate for development of generic and biosimilar drugs say the government spending bill signed by President Donald Trump includes a provision that is a giveaway to branded drug makers.

Why Price of Humira Keeps Rising Despite FDA Approval of Generic Competition

Biosimilars have so much to offer for America’s patients, but the potential savings that they can bring is being squashed by burdensome patent thickets in the name of profits,” said Christine Simmon, Executive Director of the Biosimilars Council.

Drug Pricing Proposals and Implications for Biosimilars

Biosimilars are considered a critical measure to lower drug costs, and there is a general push to increase utilization through these many pricing proposals.

California AG Fights AAM’s Bid to Block Pay-for-Delay Ban

In a court filing, California’s Attorney General is pushing back against a last-ditch effort by generic drug makers to block California’s new pay-for-delay law. (Paid Sub. Req.)

Trade Deal Leaves PhRMA out in the Cold

The Pharmaceutical Research and Manufacturers of America (PhRMA) is the lone major trade group not supporting President Trump’s new North American trade deal after the drug industry lost crucial intellectual property (IP) protections in the agreement.

Five Lessons From the 2020 Formulary Exclusions and Some Thoughts on Patient Impact

PBMs are slowly adopting provider-administered biosimilars on their pharmacy benefit formularies. Pharmacy benefit biosimilar drugs are not here yet, so PBMs have focused on provider-administered drugs.

The Biosimilar Solution to Expensive Cancer Care

“Fail-first” policies amount to insurers effectively eliminating the lower-cost biosimilars as a treatment option for patients to choose over their more expensive originator biologics. Last summer, the FTC opened an investigation into the contracting practices of Johnson & Johnson’s for infliximab originator, an auto-immune drug, Remicade.

Biologics Are Not a Natural Monopoly

Historically, economic theory states that a natural monopoly is the result of economies of scale where it is only efficient to have one firm in the industry. There is no suggestion of such economies of scale in biologics.

Featured Resources

11 out of 24 is a failing grade

Visitors to the site can access recently published AAM white papers that quantify the growing barriers that keep generics and biosimilars grom getting approved, launching onto the market, staying on the market and being covered for patients.

Member Spotlight Series

As part of the Biosimilar Council’s commitment to broad stakeholder education about the promise of biosimilars, we’ve launched the first in a series of member spotlights. We are thrilled to begin with Dr. Hillel Cohen, Executive Director, Scientific Affairs at Sandoz, Inc.

Naming Biosimilars

Suffix vs No Suffix: Naming Biologics and Biosimilars

Understanding how biologic drugs are named can alleviate stakeholder confusion and lead to great biosimilars adoption. Check out our newest infographic on biosimilar naming.

Failure to Launch White Paper Series

The Biosimilars Council found that delayed entry of biosimilars dur to brand-name biologic companies’ anti-competitive market access tactics have cost the U.S. health care system billions of dollars in lost savings.

Upcoming Events

AAM Annual Meeting: Access! 2020

May 11-13, 2020

Washington, D.C.


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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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.