Press Releases

Biosimilar Medicines Generated $7 Billion in Savings in 2021

Promise of biosimilars is being fulfilled, but market and regulatory barriers to uptake persist WASHINGTON, DC (September 21, 2022) –... Read more »
Senate passes inflation reduction act

AAM Statement on Senate Passage of Inflation Reduction Act

WASHINGTON, D.C. (August 7, 2022) – The members of the Association for Accessible Medicines (AAM) and the Biosimilars Council are extremely... Read more »
Inflation reduction act, biosimilars

Inflation Reduction Act Would Stifle Biosimilar Competition and Savings

WASHINGTON, DC (August 3rd, 2022) - Writing for Forbes, Wayne Winegarden from the Pacific Research Institute makes it clear that... Read more »
US Capitol, Build Back Better bill, BBB

AAM Statement on BBB 2.0

This flawed, untested scheme will reduce future savings through lower cost generic and biosimilar medicines for America’s patients and employers.... Read more »
Federal Trade Commission must investigate PBMs

AAM Statement in Response to Federal Trade Commission Request for Information on PBM Business Practices

WASHINGTON, DC (May 23, 2022) - Today, the Association for Accessible Medicines (AAM) and its Biosimilars Council submitted a comment... Read more »
Biosimilars Policy

Association for Accessible Medicines Names Craig Burton as Senior Vice President, Policy & Strategic Alliances, and Executive Director of the Biosimilars Council

WASHINGTON, DC (May 16, 2022) – The Association for Accessible Medicines (AAM) and its Board of Directors announced the promotion... Read more »

HHS Finds Biosimilars Use Results in “Significant Spending Reduction” For Medicare and Its Beneficiaries

Washington, D.C. (April 1, 2022) - A new study from HHS’ Office of the Inspector General (OIG) finds increasing biosimilars... Read more »

Biosimilars Council Encourages Stakeholders, Advocates to Join #GlobalBiosimilarsWeek

Washington, D.C. (October 31, 2021) – The Association for Accessible Medicines' Biosimilars Council, in accordance with the International Generic and... Read more »

Biosimilar Medicines Produce Billions in Savings in U.S., Dramatically Reduce Oncology Spending Growth: Report

WASHINGTON, D.C. (September 21, 2021) – The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), today announced... Read more »
Biosimilars Council - FDA Website Screenshot

Biosimilars Council Statement on FDA Approval of First Interchangeable Biosimilar

WASHINGTON (July 29, 2021) – AAM’s Biosimilars Council applauds the FDA's decision to award an interchangeable designation to an insulin glargine... Read more »

AAM and Biosimilars Council Statement on ACA Ruling in California v. Texas

WASHINGTON, DC – (June 17, 2021) AAM and its Biosimilars Council welcome today’s decision by the U.S. Supreme Court in… Read more »

A mother and daughter are seated at a table and a doctor is seated across from them.

Biosimilars Council Endorses The Increasing Access to Biosimilars Act

WASHINGTON, D.C. (April 29, 2021) — The Biosimilars Council supports and endorses The Increasing Access to Biosimilars Act, which would take a critical... Read more »
The White House - Washington DC, United States

The Biosimilars Council Applauds President Biden for Signing the Advancing Education on Biosimilars Act of 2021

WASHINGTON, D.C. (April 26, 2021) – The Biosimilars Council applauds President Biden’s signing of the Advancing Education on Biosimilars Act... Read more »
Doctor meets with diabetic senior woman at medical appointment

The Biosimilars Council Applauds Reintroduction of the Bipartisan BIOSIM Act

WASHINGTON, D.C. (April 23, 2021) — The Biosimilars Council, representing leading developers of biosimilar medicines, strongly supports the reintroduction, and... Read more »

Statement on IQVIA Report: Biosimilars in the U.S.: Reimbursement and Impacts to Uptake

WASHINGTON, DC (March 25, 2021) — U.S. patients rely on their health care providers to help them access biosimilars to... Read more »
aam policy agenda 117th congress

AAM Outlines Policy Solutions for Sustained Patient Access to Generic and Biosimilar Medicines

Association for Accessible Medicines Unveils Policy Agenda for Biden Administration and 117th Congress New Campaign Highlights Lifesaving Role Generic Drugs... Read more »
part d statement

AAM and Biosimilars Council Statement on CMS Decision to Update Part D Program

The Association for Accessible Medicines and its Biosimilars Council applaud the decision by CMS to update the Part D program and... Read more »
biosimilars news april 2020

AAM Statement on President-elect Biden Naming Katherine Tai as U.S. Trade Representative

WASHINGTON, DC (December 10, 2020) — The Association for Accessible Medicines and its members look forward to working with President-elect... Read more »
Xavier Becerra

AAM Statement on President-elect Biden Naming Xavier Becerra as Secretary of Health and Human Services

WASHINGTON, DC (December 7, 2020) — The Association for Accessible Medicines and its members look forward to working with President-elect... Read more »
igba global biosimilars week

IGBA Launches First Global Biosimilars Week

Contact: [email protected] Geneva, November 16, 2020 – Today the International Generic and Biosimilar Medicines Association (IGBA) launched the first ever... Read more »
Approved Biosimilars

AAM Statement on 2020 Election

AAM Statement on 2020 Election WASHINGTON, DC (November 11, 2020) — The Association for Accessible Medicines looks forward to working... Read more »
IQVIA Biosimilars in the US

Statement on IQVIA Report: Biosimilars in the U.S. 2020-2024

Council Statement on IQVIA Institute Report: Biosimilars in the United States 2020 - 2024 “Today’s IQVIA report confirms that biosimilars... Read more »

Security of the U.S. Pharmaceutical Chain

WASHINGTON, DC (August 6, 2020) — Developers of generic and biosimilar medicines support diversification of the pharmaceutical supply chain and... Read more »
increasing access to biosimilars act

Increasing Access to Biosimilars Act

The Biosimilars Council commends Senators Cornyn and Bennet for the introduction of the Increasing Access to Biosimilars Act. This bipartisan... Read more »
Key Lessons for the US From EU

Matrix Global Advisors Report Reveals Key Lessons for the United States from Europe’s Biosimilar Experience

WASHINGTON, DC (JUNE 3, 2020) — A new report from Matrix Global Advisors (MGA) details “lessons learned” from the European... Read more »

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

“Today’s FDA action to enhance the Purple Book is a boon to those seeking to bring biosimilars to America’s patients.... Read more »

Statement on CMS Specialty Tier and Generic/Biosimilar Utilization Measures Proposal – Medicare Advantage/Part D NPRM and Advance Notice

“CMS’ proposal for a separate preferred specialty tier is a very welcome and significant step that will encourage greater generic... Read more »
biologics market

Biosimilars Council Statement on FDA & FTC Collaboration to Promote Competition for Biological Products

“The Biosimilars Council welcomes FDA and FTC collaboration to fight the pervasive, intentional and anticompetitive misinformation spread depriving America’s patients access to... Read more »
interchangeable insulin

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

Guidance Would Speed Availability of Automatically Substitutable Insulin to America’s Patients WASHINGTON, DC (JANUARY 28, 2020) - The Biosimilars Council,... Read more »

Congress’ Bipartisan Efforts to Increase Patient Access to Biosimilars

Congress’ Bipartisan Efforts to Increase Patient Access to Biosimilars Respond to America’s Drug Pricing Crisis WASHINGTON, DC (OCTOBER 2, 2019)… Read more »

Biologics Sign On Letter 2019

Dear Chairman Alexander and Ranking Member Murray: On behalf of the undersigned organizations, we write to express urgent concern about... Read more »

Policy and Market Failures Stifle Biosimilar Adoption in the U.S.

Delayed Adoption of Biosimilars Has Cost America’s Health Care System $2.2 Billion Since 2015 WASHINGTON, DC (SEPTEMBER 9, 2019) —… Read more »

Statement on Stakeholder Letter to Reduce Medicare Part B Costs for Patients on a Biosimilar

Today, a coalition of over twenty stakeholders, including the American Cancer Society Cancer Action Network, CVS Health and the National... Read more »

Patent Thickets Bog Down U.S. Biosimilar Launches

Delayed Access to Biosimilars Has Cost the U.S. Health Care System $7.6 Billion Since 2015 BIOSIMILARS COUNCIL | June 25,… Read more »

AAM and the Biosimilars Council Statement on UnitedHealthcare Announcement to Reverse Course on Biosimilars

WASHINGTON, DC (May 30, 2019) — UnitedHealthcare’s (UHC) recent announcement that it will begin preferring brand name biologics over lower… Read more »

AAM and the Biosimilars Council Support Finalization of CMS Part D and Medicare Advantage (MA) Rule

WASHINGTON, DC (May 17, 2019) — “We commend CMS for its work to promote greater utilization of lower-cost generic and… Read more »

Press Statement: Biosimilars Council Commends FDA on Insulin Hearing

The Biosimilars Council commends FDA for today’s hearing on the future of insulin biosimilars. Insulin has been available to America's... Read more »

AAM and Biosimilars Council Remarks at FDA Biosimilars Public Hearing on Insulin

Christine Simmon, Executive Director, Biosimilars Council, and Senior Vice President of Policy and Strategic Alliances, AAM spoke at the Food... Read more »

AAM and Biosimilars Council Applaud FDA on Interchangeability Guidance

“AAM and the Biosimilars Council applauds the FDA’s timely guidance on interchangeability for biosimilars, particularly its streamlined data and study... Read more »

AAM and the Biosimilars Council Oppose FDA Update to Biosimilar Naming

WASHINGTON, DC (May 8, 2019) – In comments submitted yesterday to the Food and Drug Administration (FDA), the Association for Accessible... Read more »

Comments of the Association for Accessible Medicines and the Biosimilars Council regarding Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability

The Association for Accessible Medicines (AAM) and its Biosimilars Council appreciates and supports FDA’s continued efforts to foster biosimilar competition... Read more »

Diverse Stakeholder Group Expresses Concern for the Naming of Biological Products

Today, a diverse stakeholder group of 28 patient, consumer, taxpayer, employer, pharmacy, provider, health plan and other groups submitted a... Read more »

Association for Accessible Medicines and its Biosimilars Council comments to the FDA on Pfizer’s Citizen Petition

WASHINGTON, DC (MARCH 6, 2019) — The Association for Accessible Medicines (AAM) and its Biosimilars Council submitted comments in support of... Read more »

AAM & Biosimilars Council Response to Pfizer Citizen Petition

The Association for Accessible Medicines (“AAM”), and its Biosimilars Council (“Council”) (collectively referred to in these comments as AAM), are... Read more »

AAM & Biosimilars Council Comments on FDA 2015-D-4750

The Association for Accessible Medicines and the Biosimilars Council (collectively referred to as “AAM”) are pleased to provide comments to... Read more »

AAM & Biosimilars Council Comments on FDA 2011-D-0611

The Association for Accessible Medicines and the Biosimilars Council (collectively referred to as “AAM”) are pleased to provide comments on... Read more »
Biosimilars Council - Pharmacists working in Pharmacy

AAM’s Biosimilars Council Announces 3 New Members

WASHINGTON, DC (January 22, 2019)— The Association for Accessible Medicines (AAM) is pleased to announce that three new members have joined its Biosimilars Council: Accord Healthcare Inc.... Read more »

AAM & Biosimilars Council Comments Regarding FDA-2018-N-2689

The Association for Accessible Medicines (“AAM”), and its Biosimilars Council (“Council”) (collectively referred to in these comments as AAM), are... Read more »
Biosimilars Council - Bottles in Automated Processing Facility

The Association for Accessible Medicines Urges FDA to Foster Biosimilars Competition, Confidence Under Action Plan

Diverse Stakeholders Say Agency Education Efforts Must Address Misinformation Campaigns to Bolster Patient Trust WASHINGTON, DC (September 21, 2018) — The... Read more »
Biosimilars Council - Statement Image

Christine Simmon’s Remarks at FDA Public Hearing on Biosimilars

Association for Accessible Medicines’ Biosimilars Council Remarks at FDA Biosimilars Public Hearing, “Facilitating Competition and Innovation in the Biological Products... Read more »
Biosimilars Council - AAM Call to FDA Press Release - Government Building Against Blue Sky

Association for Accessible Medicines (AAM) Calls on FDA to Influence Agencies & Congress on Measures to Improve Biosimilar Competition and Lower Costs of Medicine

Stronger Policies to Encourage Biosimilar Market Growth are Essential for America’s Patients, AAM Says (White Oak, MD – Sept. 4,... Read more »
Biosimilars Council - REMs Press Release Cover Photo - Pill Bottle

New Study Finds Patients, Government and Insurance Lose $13.4B in Potential Savings By Brand Drug Companies’ Abuses

Study Finds Costs of Brand Abuses Have Exploded in 4 Years, Harming Patient Access to Affordable Generic and Biosimilar Medicines... Read more »
The Biosimilars Council - U.S.-Mexico Understanding on Biologic Exclusivity

North American Generic Drugmakers Call for Rejection of New Exclusivity Period for Biologics

Statement of the Association for Accessible Medicines, Canadian Generic Pharmaceutical Association, and Mexican Association of Generic Medicines on the Announcement U.S.-Mexico Understanding on... Read more »
The Biosimilars Council - Doctor on iPad Abstract

AAM Statement on FDA’s Biosimilars Action Plan

Agency’s Commitment to Competition, Efficient Development and Approval Process Lauded (Washington, D.C. – July 18, 2018) – The Association for... Read more »
The Biosimilars Council - 2018 Access and Savings Report Cover Zoomed In

New Study Finds Biosimilar Competition Can Lower Prescription Drug Costs

Generic and Biosimilars Industry Releases 10th Annual Access and Savings Report Highlights Potential of Biosimilars but Cautions Against Brand Efforts to... Read more »
Association for Accessible Medicine’s Biosimilars Council Releases Roadmap for Biosimilars Market Development in U.S.

Association for Accessible Medicine’s Biosimilars Council Releases Roadmap for Biosimilars Market Development in U.S.

“Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines for America’s Patients” Recommends Policies to Fulfill Promise of Biosimilars (Washington, D.C.... Read more »
The Biosimilars Council - Purple Stethoscope

IGBA Launches A Biosimilar Medicines Information Campaign

Contact: David Gaugh [email protected] Today, the International Generic and Biosimilar medicines Association (IGBA) launched an information campaign on biosimilar medicines.... Read more »
The Biosimilars Council - Researcher with Dropper

IGBA Congratulates the Australian Government for Maintaining Their Biologics Naming Convention and for Strengthening Pharmacovigilance

Contact: David Gaugh [email protected] The International Generic and Biosimilar medicines Association (IGBA) welcomes the Australian Government's decision to maintain the... Read more »
The Biosimilars Council - Doctor sitting with older patient

Poll: Majority of Seniors and Taxpayers Support Lowering Costs and Increasing Access to Medicines Under Medicare Part D

WASHINGTON, DC (Nov. 28, 2017) – The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), released a national poll today showing support for congressional action to lower out-of-pocket costs for patients and reduce federal […]

The Biosimilars - Doctor touching ipad

AAM’S Biosimilars Council Applauds CMS Decision to Revise Biosimilars Reimbursement Policy

The Association for Accessible Medicines (AAM) and its Biosimilars Council praise the Centers for Medicare & Medicaid Services (CMS) decision to revise its current biosimilars reimbursement policyin Medicare Part B, as part of the Revisions to Payment Policies under the […]

The Biosimilars Council - Doctors with hands in the middle

AAM’S Biosimilars Council Welcomes Boehringer Ingelheim

WASHINGTON, DC (October 4, 2017) — The Association for Accessible Medicines (AAM) announced today that Boehringer Ingelheim Pharmaceuticals, Inc. has joined its Biosimilars Council. Molly Burich, Boehringer Ingelheim’s Associate Director for Public Policy{…}

Biosimilars Council - Statement Image

Biosimilars Council Supplemental Comments on the CY 2018 Physician Fee Schedule

September 19, 2017 The Honorable Seema Verma Administrator Centers for Medicare and Medicaid Services (CMS) Room 445-G, Hubert H. Humphrey... Read more »

New Report Indicates Revising CMS Policy on Biosimilars Could Save $11.4 Billion On Medicines Over 10 Years

Today, the Association for Accessible Medicines (AAM) and its Biosimilars Council released an analysis finding that if the Centers for Medicare & Medicaid Services (CMS) were to revise its current reimbursement policy for biosimilar medicines […]

The Biosimilars Council - Doctor with Child

AAM Biosimilars Council Releases 2017 Report on Patient Access to Biosimilars in the US

Today, the Association for Accessible Medicines (AAM) and its Biosimilars Council announced the results of a new patient access study, “Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medicines.” […]

AAM’s Biosimilars Council Urges CMS to Revise Biosimilars Reimbursement Policy

AAM’s Biosimilars Council Urges CMS to Revise Biosimilars Reimbursement Policy

To ensure patients have access to more affordable versions of expensive biologic medicines, the Biosimilars Council today urged the Centers for Medicare and Medicaid Services (CMS) to revise its reimbursement policy for biosimilars […]

Biosimilars Council Comments on the CY 2018 Physician Fee Schedule

Revisions to Payment Policies under the Physician Fee Schedule (PFS) and Other Revisionsto Part B for CY 2018 proposed July... Read more »

AAM Statement on Senate Passage of FDA User Fee Reauthorization (FDARA)

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association, urges the Supreme Court to recognize that biosimilar medicines can generate billions […]

AAM’s Biosimilars Council Praises House Passage of the FDA Reauthorization Act of 2017

WASHINGTON, DC (July 12, 2017) – The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), issued the... Read more »

AAM Biosimilars Council Praises Unanimous Supreme Court Ruling That Will Accelerate Patient Access to Biosimilar Medicines

WASHINGTON, DC (June 12, 2017) –The Association for Accessible Medicines (AAM) applauded the U.S. Supreme Court’s decision today in Sandoz... Read more »
Biosimilars Council - Statement Image

AAM & Biosimilars Council Comments on FDA Interchangeability Guidance

Comments from AAM and the Biosimilars Council provided to the Food and Drug Administration (FDA) on the Agency's Draft Guidance... Read more »
The Biosimilar Council

AAM Biosimilars Council Urges Supreme Court…

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association, urges the Supreme Court to recognize that biosimilar medicines can generate billions […]

(FDA) Biosimilar User Fee Act Public Meeting

(FDA) Biosimilar User Fee Act Public Meeting

“I am David Gaugh, Senior Vice President of Sciences and Regulatory Affairs at the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council (Council) and a licensed pharmacist.[…]

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