Biosimilars Bulletin | February 2020

News and Updates

AAM & the Biosimilars Council Applaud FDA’s Release of Enhanced Purple Book

AAM and the Biosimilars Council issued the following statement of the FDA’s release of the enhanced Purple Book, which creates a single searchable electronic database that identifies each biosimilar and interchangeable biologic with its reference product.

FDA launches new Purple Book searchable database to help patients and prescribers identify FDA-approved biologic and biosimilar treatment options

The FDA has released the first phase of the enhancement of the “Purple Book: Database of FDA-Licensed Biological Products”, transitioning the current table format “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” to a searchable, public-facing online database.

AAM’s Biosimilars Council Applauds FDA’s Draft Guidance on Interchangeable Insulin

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), submitted comments to the Food and Drug Administration (FDA) applauding the agency for streamlining requirements for approval of biosimilar and interchangeable insulin based on sound science.

Biosimilar Information Wars: Draft Guidance Seeks to Clamp Down on Efforts to Hinder Uptake in the U.S.

The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading. (Paid Sub. Req.)

Guest View: Affordable healthcare with biosimilars

Matt DeGooyer, Regional Director of the Oregon and Washington Lupus Foundation of America discusses reforms to secure cost savings for patients and provide them access to life-saving biosimilars.

FDA’s Yim Wants U.S. to Emulate Europe On Biosimilars

In an interview with the Pink Sheet, OTBB director Sarah Yim discussed her expectations for the future of the U.S. biosimilars market, her learning experience as acting director and upcoming challenges for her office. (Paid Sub. Req.)

Will Biosimilars Ever Catch on in the U.S.?

Although the cost of branded drugs in the US tends to be much higher than in the rest of the world, there is a compensatory steep drop in price once market exclusivity ends. Thus in the U.S. we see generic drug prices often reduced by as much as 90% or more, with uptake then rising accordingly.

Biosimilars Council 2019 Year in Review

2019 was a whirlwind year for biosimilars, highlighted by a record 10 U.S. Food and Drug Administration (FDA) approvals and increased uptake and utilization rates by payers.

“What Would Kaiser Do?” Changing The Employer Mindset About Biosimilars

Biosimilar Development reporter Anna Rose Welch sits down with a group of industry leaders to discuss the topic of biosimilar market access.

Featured Resources

DoesntAddUp.com

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.

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.

Register

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.accessiblemeds.org.