RESOURCES
Our mission is to serve as a resource of timely, credible information about biosimilars. Please visit this page regularly or follow us on Twitter for the latest updates on Biosimilars infographics, educational material, and FDA regulatory information.
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Letter of Support for PBM Reform
Over 80 major patient organizations, health care providers, employers, and research organizations signed onto a letter by the Crohn’s & Colitis Foundation and the National Multiple Sclerosis Society urging Congress to pass meaningful PBM reform to ensure patients have access to the medicines they need.
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Setting the Record Straight on Biosimilar Interchangeability
Patients should understand that biosimilars are fully vetted through a vigorous, lengthy FDA review process, and offer the same clinical benefits and effectiveness of the originator biologic. Still, much confusion exists about interchangeability, especially with Senate Bill S. 2840 working its way through Congress.
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Transitioning from a Reference Biologic to a Biosimilar is Safe and Effective
Biosimilars are fully vetted through a vigorous, lengthy FDA review process, and offer the same clinical benefits and effectiveness of the originator biologic.
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Biosimilars: Non-Medical Switching and Transitioning
As more biosimilars launch in the United States and achieve greater availability on formularies, it is important that patients understand the different between ‘Non-Medical Switching’ and ‘Transitioning’.
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Streamlining Biosimilar Development: The Developer’s Perspective One-Pager
Advancing the evolution of biosimilar development to reflect today’s current science and available evidence will provide long-term sustainability to the biosimilar industry while enabling patients to access more and a wider variety of biological drugs without impacting safety or effectiveness.
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Biosimilars Forum Comments on BsUFA III Research Roadmap
Biosimilars Forum comments to the FDA on measures that can be adopted to streamline biosimilar development in the US and abroad.
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Shared Savings Programs in Europe
In this IQVIA report, five case studies of shared savings/benefit sharing programs from across Europe are examined using secondary research, expert interviews and IQVIA data.
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Inflation Reduction Act – ASP+8 Biosimilars Payment Increase
CMS is implementing a temporary payment increase for qualifying biosimilars under Medicare Part B. This temporary add on payment will encourage physicians to prescribe biosimilars, helping build a competitive biosimilars market leading to sustainable long term savings for patients and the Medicare program. Increasing access to lower-cost biosimilars will lead to long term savings of up to $8.2 billion in taxpayer dollars over the next 10 years.
Download the below statement and external FAQs from CMS to learn more.
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Biosimilars: Non-Medical Switching and Transitioning
‘Non-Medical Switching’ and ‘Transitioning’: An Explanation for Patients. Download the below one-pager to learn more.
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Humira® Biosimilars: Reaching the Market’s Cost-Savings Potential
In 2023, a wave of biosimilars for Humira® (adalimumab) are set to hit the market. The next 18 months will be consequential in determining the future success of the biosimilars market in the U.S. Download the below one-pager to learn more.
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Biosimilars 101 Webinar Case Study
The Biosimilars Forum hosted Biosimilars 101: An Educational Webinar on Biosimilars on Tuesday, May 10. Download the below case study to learn more about the event’s objectives and results.
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Biosimilars Forum Comments on PBM Business Practices
Biosimilars Forum response to the Federal Trade Commission’s solicitation for public comments on the business practices of Pharmacy Benefit Managers and their impact on independent pharmacies and consumers.
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Saving Billions on Healthcare Costs with Biosimilars
Biosimilars are safe, effective treatment options that can lower the price of prescription drugs and help close significant equity gaps within our healthcare system.
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Biosimilars Basics
Biosimilars are safe and effective biologic medications that are used to treat a variety of conditions. Learn more about the basics of biosimilars.
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Separate Codes and Payment for Biosimilars
The Biosimilars Forum supports the current Medicare Part B coding policy of assigning unique Healthcare Common Procedure Coding System (HCPCS) codes and a separate payment rate to each individual biosimilar.
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Biosimilars Have Significantly Lowered Prices of All Biologics
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Biosimilars Forum Economic Footprint
The Biosimilars Forum is a nonprofit organization that educates stakeholders and policymakers on the safety and efficacy of biosimilars, as well as advocates for policies that remove the barriers to accessing and using these lower-cost medicines. The Forum’s member companies employ more than 60,000 people across 104 facilities in 27 states, Washington D.C., and Puerto Rico.
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Polling Shows Strong Bipartisan Support for Immediate Action on Biosimilars to Reduce Health Care Costs
A clear majority of voters across party lines favor immediate action to lower drug prices by acting to increase use of biosimilars, according to a new HarrisX poll. The findings underscore the need for policymakers to pursue commonsense policy reform that will reduce patients’ health costs and increase access to critical biosimilars therapies.
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FDA Patient Materials
Patient and prescriber education on biosimilars is critical to drive increased use of these life-saving therapies — bringing more treatment options and significant savings to patients and the U.S. health care system. The U.S. Food and Drug Administration (FDA), after direct feedback from patient advocacy groups and key stakeholders on the need for greater biosimilar education, developed new Patient Materials to increase awareness and understanding of the benefits of biosimilars.
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State Laws and Biosimilars
Find out about state laws and legislation related to biologic medications and substitution of biosimilars.
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Five Things to Know About Biosimilars
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Awareness, Knowledge & Perceptions of Biosimilars among Specialty Physicians
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States Continue to Pass Biosimilar Substitution Laws in 2018
“The Biosimilars Forum is encouraged that so far this year, five more states – Michigan, South Dakota, West Virginia, Wisconsin and Wyoming – have enacted legislation that will help their residents and health care systems benefit from the promise of biosimilars. With 41 states now having passed biosimilar laws allowing substitution of biosimilars designated as interchangeable, patients and doctors can be encouraged that in most states, pathways which support access to these affordable and effective treatment options are taking shape.
“We look forward to policymakers at both the state and federal level continuing to play a role in developing a vibrant biosimilars market, which could lead to a transformation in the way Americans manage serious diseases including cancer, diabetes, rheumatoid arthritis and other chronic conditions.” – Juliana M. Reed, President, Biosimilars Forum.
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FDA Guidance: Additional Q&A Regarding Implementation of the BPCIA (2021)
Answers to common questions from manufacturers or applicants interested in developing proposed biosimilar products (revised from 2012)
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FDA Guidance: Q&A Regarding Implementation of the BPCIA (2021)
Answers to common questions from manufacturers or applicants interested in developing proposed biosimilar products
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FDA Draft Guidance: Reference Product Exclusivity
Draft guidance for sponsors developing biological products to help FDA determine date of first licensure for reference product
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FDA Draft Guidance: Clinical Pharmacology Data Use
Draft FDA guidance to assist with design and use of clinical pharmacology studies to support determination that proposed product is biosimilar to the reference product
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FDA Guidance: Quality Considerations for Demonstrating Biosimilarity
Final guidance describes FDA’s recommended factors to consider when demonstrating biosimilarity
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FDA Guidance: Scientific Considerations in Demonstrating Biosimilarity
Final guidance to assist biosimilars makers in demonstrating biosimilarity of proposed product to the reference product
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Biosimilars: More Treatment Choices and Innovation
FDA article on the impact of biosimilars on access and health
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Biologics Price Competition and Innovation Act of 2009
The abbreviated FDA licensure pathway law
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FDA Information on Prescribing Biosimilars
FDA information regarding the prescribing of biosimilars
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FDA Information on Prescribing Interchangeable Biosimilar Products
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Analysis Shows Biosimilars Lower Patient Costs
While biosimilars are known to reduce healthcare costs overall, many patients want to know exactly how much biosimilars can save them in out-of-pocket spending. A recent analysis presented at the Academy of Managed Care Pharmacy in October 2018 compared patient out of pocket responsibility for Zarxio® (filgrastim-sndz) and Neupogen® (filgrastim). The analysis found that patient costs were approximately 9% lower for the biosimilar than for the original biologic. This could result in a savings of more than $8 million for Medicare beneficiaries nationwide.
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Structural Market Changes Needed to Achieve Cost-Savings from Biosimilars
The Biosimilars Forum and Medicines for Europe released a joint report today exploring how European countries have successfully instituted and sustained a multi-source, competitive biosimilars market over the last decade. The report also lays out a roadmap for United States (U.S.) policymakers to ensure that patients have access to the treatments they need and that the healthcare system at-large achieves the significant potential for cost-savings associated with a vibrant biosimilars market.
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Science-Based Resource on the Basic Facts About Biosimilars
In order to promote the uptake of biosimilars across the U.S., stakeholders must be informed about the basic science of these important medicines. Created out of the Biosimilars Forum’s Biosimilars Roundtable (formerly the Biosimilars Forum Stakeholder Workshop group), this two page document incorporates feedback from nearly 40 stakeholder groups, from patient advocacy organizations to physician and payer groups, and presents the basic knowledge that all stakeholders need to know about the safety and efficacy of biosimilars, including answers to common myths about them.
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