Advocacy

Advocacy

In 2015, the first biosimilar was approved in the United States. Since then, 31 have been approved by the FDA and 20 are on the U.S. market.
Biosimilars expand access to high-quality treatment options for clinicians and patients while reducing costs to families, caregivers,
public and private insurance plans, and the health care system.

Below is a database for the latest Biosimilars Forum statements on pressing policies, FDA resources on biosimilars for providers, patients, and industry professionals, along with recent news stories on developments within the biosimilars landscape.

Biosimilars Forum Statements:

For the Biosimilars Forum’s statements regarding items of interest to the biosimilars community, please visit our News page.

Links to Biosimilars Information from the FDA:

Biosimilars Forum: State Biosimilars Substitution Compromise

Biosimilars Forum position on State Biosimilars Substitution Compromise

CMS/Biosimilars Reimbursement

Biosimilars in the News

December 12, 2024 Biosimilars Forum Welcomes Henlius as Newest Member
August 15, 2024 Biosimilars Forum Calls on CMS to Support Lower-Cost Biosimilars and Increase Access for Patients
July 24, 2024 The Biosimilars Forum Supports House Committee on Oversight and Accountability Probe Into the PBM Monopoly
July 9, 2024 Biosimilars Forum Calls for Reform of the PBM Monopoly
March 20, 2024 Biosimilars Forum Announces Support for Increasing Access to Biosimilars Act
March 14, 2024 Biosimilars Forum Urges Congress to Support Free Market Competition and Lower Prescription Drug Prices for Patients by Reforming Pharmacy Benefit Managers
January 24, 2024 Biosimilars Forum Welcomes Teva as Newest Member
January 10, 2024 Biosimilars Forum Welcomes Biocon Biologics as Newest Member
November 30, 2023 Julian Malasi Member Spotlight
November 16, 2023 Affordable prescription drugs exist — why can’t more patients access them?
November 3, 2023 Biosimilars Forum Supports Senate Finance Committee Legislative Discussion Draft Promoting Biosimilars
November 2, 2023 Biosimilars Forum Announces Support for Bipartisan Interchangeability Legislation
October 17, 2023 Biosimilars Forum Welcomes Meitheal Pharmaceuticals as Newest Member
October 10, 2023 Biosimilars Forum Welcomes Amneal as Newest Member
August 30, 2023 Biosimilars Forum Statement on CMS Announcement of Drug Negotiation List
August 7, 2023 Biosimilars Forum Scientific Publication Identifies Pathway to Streamlined Development for Biosimilars
July 25, 2023 Biosimilars Forum Applauds Boehringer Ingelheim for Launch of Cyltezo®
July 10, 2023 Biosimilars Forum Congratulates Fresenius Kabi for Launch of IDACIO®
July 6, 2023 Biosimilars Forum Applauds Sandoz for Launch of Hyrimoz®
July 6, 2023 Biosimilars Forum Applauds Organon and Samsung Bioepis for Launch of HADLIMA™
July 5, 2023 Biosimilars Forum Applauds Coherus for Launch of YUSIMRY™
June 30, 2023 Delivering on a Watershed Moment for Biosimilars and Patients
April 10, 2023 Biosimilars Key to Lowering Healthcare and Prescription Drug Costs, According to Employers
March 30, 2023 Biosimilars Forum Applauds the U.S. Senate Finance Committee for Holding PBMs Accountable for Prioritizing Profits over Patients
March 3, 2023 Biosimilars Forum Applauds Congressman Hudson for Supporting Biosimilars Through Shared Savings Legislation
January 31, 2023 The Biosimilars Forum Calls on Decisionmakers to Deliver on Humira Biosimilars
November 10, 2022 Dorothy McCabe Member Spotlight
November 3, 2022 Biosimilars Forum Wins Global Biosimilars Industry Partner of the Year at Global Generics & Biosimilars Awards
October 4, 2022 Biosimilars Forum Applauds CMS Biosimilars Measure
October 4, 2022 Inflation Reduction Act – ASP+8 Biosimilars Payment Increase
September 20, 2022 ASP +8: CMS Releases Biosimilars Information
August 6, 2022 Biosimilars Forum Warns Limited Negotiation Policies Will Stymie Innovation
July 28, 2022 Hillel Cohen Member Spotlight
July 21, 2022 The Biosimilars Forum Launches Updated Website Content
July 14, 2022 Rebecca Mandell Member Spotlight
June 22, 2022 The Biosimilars Forum Welcomes Legislation to Hold PBMs Accountable for Unfair Practices
June 21, 2022 Rachel Turow Member Spotlight
June 16, 2022 Brian Lehman Member Spotlight
June 7, 2022 The Biosimilars Forum Commends FTC for Probe into PBMs
June 6, 2022 Biosimilars Forum Welcomes Fresenius Kabi
May 17, 2022 Tiffany Fletcher Member Spotlight
April 6, 2022 Biosimilars Forum Letter to Senate HELP Committee on FDA User Fee Agreements
March 31, 2022 HHS Inspector General Report: Biosimilars Could Generate Significant Medicare Part D Savings
March 9, 2022 Biosimilars Forum Executive Director to Discuss Current Biosimilars Landscape at World Biosimilars Congress
March 2, 2022 The Biosimilars Forum Calls on President Biden to Incentivize Biosimilars to Lower Prescription Drug Costs
March 1, 2022 Biosimilars Forum Welcomes HHS Inspector General Study on Biosimilars in Medicare Part B
February 22, 2022 Report Highlights Employer Savings from Increased Employee Access to Biosimilars
February 15, 2022 The Biosimilars Forum Congratulates Dr. Robert Califf on His Confirmation as FDA Commissioner
February 3, 2022 Biosimilars Forum Supports the Negotiated BsUFA III Agreement in Capitol Hill Testimony
January 31, 2022 Juliana M. Reed Named Executive Director of the Biosimilars Forum
November 12, 2021 The Biosimilars Forum Congratulates Robert Califf on His Nomination for FDA Commissioner
October 26, 2021 Biosimilars Forum to Congress: Incentivize Biosimilars in Build Back Better Act
October 21, 2021 Biosimilars Forum Member Spotlight: 5 Questions for Samsung Bioepis
October 20, 2021 First Biosimilar to Treat Eye Disease Gains FDA Approval
October 20, 2021 Biosimilars Forum Applauds FDA’s Approval of Second Interchangeable Biosimilar
October 13, 2021 New Report Finds Biosimilars Could Save States Billions of Dollars Annually
September 20, 2021 Senator Wyden, fulfill your promise to lower drug costs for Oregonians by increasing access to next generation generics known as biosimilars
September 20, 2021 Senator Carper, fulfill your promise to lower drug costs for Delawareans by increasing access to next generation generics known as biosimilars
September 9, 2021 Biden Administration’s Plan to Lower Prescription Drug Prices Supports Biosimilar Competition, which will Decrease Drug Costs
August 12, 2021 President Biden’s Plan to Lower Drug Prices Highlights Need for Competition from Biosimilars
August 11, 2021 Biosimilars Forum Member Spotlight: 5 Questions for Organon
July 29, 2021 FDA’s Approval of First Interchangeable Biosimilar Product Paves Way for Lower Health Care Costs for Patients
July 15, 2021 Food & Drug Administration Takes Strong Enforcement Action Against Biosimilar Misinformation
July 9, 2021 President Biden’s Executive Order to Support Biosimilar Drugs Will Provide Lower Cost Options for Patients
July 8, 2021 Morning Consult: Expanding Access to Biosimilars Has Bipartisan Support. But Movement on Legislation Hangs in the Balance of the Drug Pricing Debate
June 30, 2021 Biosimilars Forum Member Spotlight: 6 Questions for Coherus
June 24, 2021 Organon Joins Biosimilars Forum
June 21, 2021 Lowering Prices with Biosimilars: ASP+8: Stakeholder Meeting Round-Up
June 18, 2021 It’s time we fulfill the ACA’s promise to broaden access to lower-cost drugs
June 17, 2021 The Biosimilars Forum Applauds SCOTUS Decision to Uphold ACA and US Pathway for Biosimilar Approval
June 14, 2021 New Report Shows Biosimilars Significantly Lowered Prices of All Biologics
May 18, 2021 House Oversight Committee Spotlights Anticompetitive Practices Blocking Access to Lower Cost Biosimilars
April 30, 2021 Senators Cornyn and Bennet Introduce Bipartisan Legislation to Incentivize Biosimilars, Lower Cost for Seniors
April 28, 2021 Biosimilars Forum Calls for Bipartisan Policies That Lower Drug Prices on Expensive Biologics Ahead of President Biden’s Joint Session of Congress Address
April 27, 2021 Congressmen Tonko and Gibbs Introduce Bipartisan Legislation to Increase Transparency and Use of Biosimilars in Medicare Plans
April 26, 2021 President Biden Signs the Advancing Education on Biosimilars Act Into Law
April 23, 2021 Congressmen Kurt Schrader and Adam Kinzinger Introduce Bipartisan Legislation to Lower Drug Costs, Incentivize Biosimilars
April 14, 2021 Congress Passes Legislation to Lower Health Care Costs Through Bolstering Biosimilars Education
April 14, 2021 Biosimilars Forum Member Spotlight: 5 Questions for Viatris
April 5, 2021 Value of Biosimilars in Women’s Health: HealthyWomen Roundtable Series Roundup
March 23, 2021 The Biosimilars Forum Statement on the 11-Year Anniversary of the ACA and BPCIA
March 18, 2021 Biosimilars Forum Statement on The Confirmation of Xavier Becerra As U.S. Secretary of Health And Human Services
March 18, 2021 New Economic Report Demonstrates How Biosimilar Competition Lowers Prices
November 30, 2020 Viatris Inc. Joins Biosimilars Forum
November 23, 2020 The Biosimilars Forum Announces Meaghan Rose Smith as Executive Director
November 19, 2020 Biosimilars Forum Statement at FDA’s BsUFA III Kick-off Meeting
October 6, 2020 Biosimilars Could Generate $100 Billion in Savings Over Next Five Years, New Report Finds
September 21, 2020 U.S. Taxpayers and the Health Care System At-Large Have Lost out on Nearly $20 Billion in Savings Since 2018
September 10, 2020 The Biosimilars Forum Filed Comment on FDA’s Notice Detailing the Impact of Disclosure Statements in Biosimilar Promotional Materials
July 31, 2020 ICYMI: Experts Detail How Shared Savings Model for Biosimilars Could Provide Savings for Seniors, Patients and Medicare
July 31, 2020 MedPac: Top 10 Most Expensive Medicare Part B Drugs are Originator Biologics
July 24, 2020 Trump Administration’s Drug Plan Must Include Biosimilars to Lower Costs for Seniors and Medicare
July 14, 2020 ICYMI: House Appropriators Encourage CMS to Support Biosimilars; Experts Point to Biosimilars to Help Lower Drug Costs, Call on Congress and Administration to Act
July 1, 2020 The Biosimilars Forum Applauds Senators Cornyn and Bennet’s Introduction of Legislation to Lower Health Costs by Supporting Biosimilars
June 22, 2020 The Biosimilars Forum To Provide Comment at FDA’s Annual Meeting on the Biosimilar User Fee Program
May 28, 2020 Bringing Down Federal Spending: A Biosimilars Shared Savings Model To Lower Health Care Costs
May 27, 2020 Robust Biosimilars Market Could Save U.S. Taxpayers $7 Billion Annually, New Analysis Finds
May 21, 2020 AMA: U.S. Health Insurance Plans Prefer Brand Biologics Twice as Often as Lower-Cost Biosimilars
April 30, 2020 ICYMI: After Congress Approved $3 Trillion in Spending Amid the COVID-19 Pandemic, Biosimilars Can Reduce Health Care Costs for Employers and the U.S. Health Care System
April 27, 2020 ICYMI: Expert Encourage Increasing Biosimilar Use to Lower Health Care Costs; Study Finds Biosimilars Could Lower Employers Insurance Costs
March 31, 2020 Self-Insured Employers Could Have Saved Up to $1.4 Billion in 2018 with Lower-Cost Biosimilars
March 13, 2020 ICYMI: This Week, HHS Secretary Azar, Congressman Burgess, Physicians and Patients Pointed to Biosimilars to Save Seniors and Taxpayers Money; Congress Introduces Two Bills to Lower Costs with Biosimilars
March 13, 2020 The Biosimilars Forum Applauds Senators McSally (R-AZ) and Jones (D-AL) Introduction of S. 3466, the ACCESS for Biosimilars Act of 2020
March 11, 2020 The Biosimilars Forum Supports Congressmen Cardenas, Hudson, Fitzpatrick, & Craig Introduction of H.R. 6179 — Lowering Costs For Taxpayers and Medicare Seniors with Biosimilars
March 5, 2020 The Importance of Dispelling Misinformation About Biosimilar Therapies
February 10, 2020 White House Budget Proposal Recognizes Urgent Need to Increase Patient Access to Lower-Cost Biosimilars
February 4, 2020 President Trump Can Look to Biosimilars to Keep Promise of Saving Americans Billions in Health Care Costs
February 3, 2020 Biosimilars Forum Praises FTC and FDA Action to Fight Anticompetitive Behaviors Blocking Access to Lower Cost Biosimilars
December 12, 2019 Biosimilars Forum Statement on Policies Supporting Biosimilar Uptake in Canadian Market
December 12, 2019 Biosimilars Forum Congratulates Dr. Stephen Hahn on Confirmation to Lead the Food and Drug Administration (FDA)
November 25, 2019 ICYMI: Biosimilars are a Recognized, Bipartisan Solution to Lowering Health Care Costs; Nominee for FDA Commissioner Reinforces Need to Increase Access for Biosimilars
November 20, 2019 Biosimilars Forum Statement Regarding Nomination of Dr. Stephen Hahn as Next Commissioner of the Food and Drug Administration (FDA)
November 13, 2019 The Biosimilars Forum Reacts to CMS Report on Increased Medicare Premiums for Seniors
November 11, 2019 ICYMI: Trump Administration’s Joe Grogan Recognizes Need for Biosimilar Incentives to Help Lower Healthcare Costs
October 18, 2019 The Biosimilars Forum Applauds Launch of New FDA Performance Dashboard
October 9, 2019 The Biosimilars Forum Applauds Congressmen Paul Tonko (D-NY) and Bob Gibbs (R-OH) for Introducing Legislation Mandating a CMS Star Ratings Program for Biosimilars
October 3, 2019 President Trump Can Easily Reduce Health Care Costs for U.S. Seniors and Taxpayers by Increasing Biosimilar Use
October 3, 2019 New Analysis Confirms All 50 States Stand to Benefit from Increased Use of Biosimilars
October 1, 2019 The Biosimilars Forum Applauds Congressmen Scott Peters, Pete King and Anthony Brindisi For Introducing $0 Copay Biosimilars Legislation for Medicare Part B
September 20, 2019 The Biosimilars Forum Applauds Bipartisan Introduction of the BIOSIM Act
September 19, 2019 House Energy & Commerce Committee Hearing Highlights How Biosimilars Can Save Patients Money
September 9, 2019 Biosimilars Forum’s Public Letter In Response to Anti-Biosimilars Op-Ed
August 22, 2019 New Analysis Encourages Employer Engagement to Help Realize Significant Savings Potential of Biosimilars
July 30, 2019 Forum Statement in Response to Senate Finance Committee Advancing its Drug Pricing Package
July 25, 2019 Forum Statement on Senate Finance Provision and New Amendment That Could Save Taxpayers and Seniors Billions
July 23, 2019 Senate Finance Provision Increasing ASP for Biosimilars Could Unlock Billions in Savings for Patients and Taxpayers
July 11, 2019 New Analysis Confirms Increased Use of Biosimilars Can Save U.S. Up to $71 Billion Over a Decade
June 20, 2019 Health Experts Agree Increasing Biosimilar Use Can Help Reduce Rising Drug Costs for Patients
May 29, 2019 Biosimilars Forum Announces Support for Policies that Would Save Taxpayers and Seniors Billions
May 23, 2019 The Biosimilars Forum Commends Senate HELP Committee’s Effort to Educate Patients and Providers on Biosimilars
May 10, 2019 The Biosimilars Forum Comments on FDA’s New Interchangeability Guidance for Industry
March 19, 2019 Significant Healthcare Savings Possible if U.S. Cultivates a Robust Biosimilars Market
March 7, 2019 The Biosimilars Forum Disagrees with the Food and Drug Administration’s Decision on Naming of Biologic Medicines
March 6, 2019 The Biosimilars Forum Recognizes Commissioner Gottlieb’s Leadership Supporting a Strong Biosimilars Market in the U.S.
February 26, 2019 Removing 340B Pass-Through Would be Detrimental to US Healthcare Savings
February 26, 2019 The Biosimilars Forum Urges Senate Finance Committee to Seek Meaningful Biosimilars Reform
February 12, 2019 The Biosimilars Forum Objects to Consolidate Billing of Biosimilars
February 1, 2019 The Biosimilar Forum Recognizes Leah Christl’s Departure from FDA
January 31, 2019 The Biosimilars Forum Applauds HHS Proposal to Target Costly Rebates Structure Blocking Patients from Biosimilars and Savings
December 13, 2018 The Biosimilars Forum Commends FDA for Commitment to Increase Patient Access to Biosimilars
December 4, 2018 Biosimilars Forum Statement on Citizen Petition to the Food and Drug Administration
December 3, 2018 Biosimilars Forum Announces Launch of Biosimilars Roundtable
October 10, 2018 New White Paper Finds Biosimilars Could Drive Greater Value Beyond Price for Healthcare System
August 9, 2018 Biosimilars Forum Statement on CMS Announcement Regarding Medicare Advantage
July 18, 2018 Biosimilars Forum Applauds Biosimilars Action Plan Released by FDA Commissioner Scott Gottlieb
July 16, 2018 Biosimilars Forum Submits Comments on HHS Blueprint to Lower Drug Prices
July 12, 2018 Biosimilars Forum Commends FDA Commissioner For Raising Awareness Of Biosimilars
July 9, 2018 Biosimilars Forum Convenes Stakeholder Groups to Discuss Advancing Biosimilars
June 27, 2018 Biosimilars Forum Releases Position on Non-Medical Switching
June 21, 2018 Biosimilars Forum Applauds FDA Decision to Reevaluate Draft Guidance
May 16, 2018 Biosimilars Forum Applauds Approval of 10th Biosimilar in United States
May 11, 2018 Biosimilars Forum Encouraged by Trump Administration’s Support for Biosimilars
March 9, 2018 Biosimilars Forum Encouraged By Food And Drug Administration Commissioner’s Support of Biosimilars
February 22, 2018 Biosimilars Forum Opposes Efforts to Prohibit Biosimilars From Receiving Pass-Through Payment Status
February 12, 2018 Biosimilars Forum Supports Inclusion of Biosimilars in the Medicare Coverage Gap Discount Program
November 2, 2017 Biosimilars Forum Applauds CMS Decision to Reverse Existing Rule on Biosimilar Reimbursement Policy
October 24, 2017 Biosimilars Forum Applauds Food and Drug Administration on New Educational Program Promoting Safety and Effectiveness of Biosimilars
September 14, 2017 Biosimilars Forum Opposes Current CMS Rule That Would Adversely Affect Biosimilars Development in the U.S.; Submits Comments on Appropriate Biosimilar Reimbursement Policy
August 19, 2017 Biosimilars Forum Applauds President Trump for Signing the FDA Reauthorization Act
August 3, 2017 Biosimilars Forum Applauds Senate Passage of the FDA Reauthorization Act
July 19, 2017 Biosimilars Forum Makes Available Xcenda Study on Budgetary Impact of Biosimilars Coding
July 14, 2017 Biosimilars Forum Applauds CMS Decision to Revisit Biosimilars Coding Policy
May 12, 2017 Biosimilars Forum Applauds Senator Roberts, Reps. Barton, Eshoo for Leadership on Medicare Policy on Biosimilar Coding
May 11, 2017 Biosimilars Forum Statement Regarding Newly Released EMA Information Guide on Biosimilars For Healthcare Professionals
May 10, 2017 Biosimilars Forum Statement Regarding Confirmation of Dr. Scott Gottlieb as Commissioner of the Food and Drug Administration
May 3, 2017 Biosimilars Forum Submits Comments in Response to FDA’s Draft Guidance for Industry on Interchangeability for Biosimilar Products
March 14, 2017 Biosimilars Forum Congratulates Seema Verma on Confirmation as Next Administrator of the Centers for Medicare and Medicaid Services
March 13, 2017 Biosimilars Forum Statement Regarding Nomination of Dr. Scott Gottlieb as Next Commissioner of the Food and Drug Administration
March 2, 2017 Past President of Biosimilars Forum Testifies before Congress Regarding BsUFA
January 17, 2017 Biosimilars Forum Statement Regarding FDA’s Draft Guidance for Industry on Interchangeability for Biosimilar Products
January 12, 2017 Biosimilars Forum Statement Regarding FDA’s Final Guidance on Nonproprietary Naming of Biosimilar Products
January 11, 2017 Biosimilars Forum Statement Regarding the CMS’ Treatment of Biosimilars Under the Medicaid Drug Rebate Program
November 1, 2016 Awareness of Biosimilars Among U.S. Specialty Physicians is High but New Survey Identifies Five Major Knowledge Gaps
October 20, 2016 Biosimilars Forum Submits comments on FDA Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022
September 16, 2016 Biosimilars Forum Applauds Outcome of BsUFA Negotiations; Pleased to Have Played Important Role in Decision-Making
June 3, 2016 Biosimilars Forum Submits Comments in Response to FDA Draft Industry Guidance on Labeling for Biosimilar Products
March 31, 2016 Biosimilars Forum Issues Statement on FDA Draft Industry Guidance on Labeling for Biosimilar Products
March 16, 2016 Biosimilars Forum Issues Statement on Proposed Part B Drug Payment Model
February 9, 2016 Biosimilars Forum Statement: FDA Arthritis Advisory Committee Meeting for Biosimilar to Remicade (Infliximab), Submitted by Celltrion, Inc.
February 4, 2016 Biosimilars Forum Issues Statement Regarding House Energy & Commerce, Subcommittee on Health Biosimilars Hearing, Launch of New Biosimilars Education Initiative
February 1, 2016 Biosimilars Forum Launches “Partnership for Biosimilars Education and Access”
November 5, 2015 EPIRUS Biopharmaceuticals Joins Biosimilars Forum to Help Educate Patients and Health Care Providers on Importance of Biosimilars
October 30, 2015 Biosimilars Forum Disappointed with CMS Final Rule on Biosimilar Payment and Coding
October 27, 2015 Biosimilars Forum Comments on FDA Naming Guidance
October 8, 2015 Biosimilars Forum Applauds Senators Roberts, Carper for Leadership on Proposed Medicare Rule on Biosimilar Coding
September 8, 2015 Biosimilars Forum Issues Comments for CMS Proposed Rule on Biosimilar Payment and Coding
September 3, 2015 Biosimilars Forum Statement on the Introduction of Biosimilars in the United States
August 27, 2015 Forum Statement on Proposed FDA Guidance on Naming of Biological Products
August 5, 2015 Biosimilars Forum Applauds Reps. Barton, Eshoo for Leadership on Proposed Medicare Rule on Biosimilar Coding
July 9, 2015 Biosimilars Forum Expresses Concern with CMS Proposed Rule on Biosimilar Payment and Coding
May 5, 2015 Biosimilars Forum Statement Regarding the Need for Appropriate Coding for Biosimilars
May 5, 2015 New Forum Launches to Expand Access to Biosimilar Medicines, Improve Health Care