Biosimilars Council

NEW THIS WEEK! The 2024 U.S. Generic & Biosimilar Medicines Savings Report

Since the first launch in 2015, patients and the U.S. healthcare system have saved around $36 billion. Although savings have grown, biosimilar adoption remains too low! Learn about how PBM formulary practices favoring high-priced brand biologics with high rebates prevent patient access to lower-cost biosimilars: https://biosimilarscouncil.org/resource/2024-us-generic-biosimilar-savings-report/

JUST RELEASED! saved patients & the U.S. healthcare system $12.4 billion in 2023. Imagine the additional savings that would come from legislative and regulatory actions aimed to support new biosimilar adoption! Learn more in our 2024 (link in comments).

Are there any risks associated with switching between a reference product and an ? Short answer: No! ❌ To meet the FDA’s requirements for interchangeability, a biosimilar must be as safe and effective as its reference product, and produce no meaningful difference in treatment—​meaning there are no inherent risks in switching.

Find the answers to more of your FAQ's surrounding interchangeable , here:https://biosimilarscouncil.org/wp-content/uploads/2023/12/2023-Biosimilar-Interchangeability-FAQs.pdf

Did you know a drug manufacturer must specifically seek an designation? This means that a lack of an interchangeable designation on a product may simply indicate that the manufacturer did not seek the designation or that the additional data required has not yet been provided. This does not mean that an interchangeable biosimilar is safer or more effective than other biosimilar medicines.

Learn more about how are tested for interchangeability:https://biosimilarscouncil.org/wp-content/uploads/2023/12/2023-Biosimilar-Interchangeability-FAQs.pdf

Are you ready for ? This year’s campaign “Advancing Access to Biosimilars” runs from Nov 11–15. Visit https://www.globalbiosimilarsweek.org for the latest information, social media toolkit and downloadable resources you need to help you plan your participation.

Wondering if are as safe and effective as reference biologics? 🤔

Learn the answer to this question and more in our handy Biosimilar Interchangeability FAQ's:https://biosimilarscouncil.org/wp-content/uploads/2023/12/2023-Biosimilar-Interchangeability-FAQs.pdf

PRESS RELEASE📣

“An interchangeable designation has no bearing on the safety, effectiveness or quality of a biosimilar,” said Craig Burton, Executive Director for the Biosimilars Council. “We agree with the draft guidance which states, experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a product.”

U.S. Food and Drug Administration
Association for Accessible Medicines

Biosimilars Council Submits Comments, Applauds FDA Draft Guidance Regarding Interchangeability The Biosimilars Council commented this week on the FDA’s June 2024 Draft Guidance Docket.

Did you know our Biosimilars Council works to increase patient access to lifesaving, affordable medicines⁉️ We strive to create a positive regulatory, reimbursement, political and policy environment to assure critical medicines thrive — ensuring billions in savings to patients and the health care system. Learn more about who we are and what we do, here: https://biosimilarscouncil.org/about-biosimilars-council/

medicines have the potential to save patients $130 billion by 2025 — but only if we work together to make it possible. Show support today by learning more about critical biosimilars advocacy issues: https://biosimilarscouncil.org/advocacy/

Did you know all , whether they have an “interchangeable” designation or not, are rigorously tested and approved by the FDA and are certified to have “no clinically meaningful differences” from the original “reference” biologic?

Gain deeper insight into what interchangeability means when it comes to biosimilars in our Biosimilar Interchangeability FAQ's:https://biosimilarscouncil.org/wp-content/uploads/2023/12/2023-Biosimilar-Interchangeability-FAQs.pdf

The market for FDA-approved has expanded, now nearly 30% of the overall biologics market. The average sales price for biosimilars is on average 50% less than the reference brand biologic medicine. Visit https://biosimilarscouncil.org/resource/fda-approved-biosimilars/ to find an updated list of all FDA-approved biosimilars on our Biosimilars Council website!

🗓️ Save the Date! The 2024 edition of will be held November 11-15. We're calling on stakeholders, patients, health care professionals and their organizations
around the world to share their biosimilars stories. Learn more at https://www.globalbiosimilarsweek.org/.

The Biosimilars Council sets the record straight: Biosimilars are safe and effective for patients.

While we applaud the U.S. Food and Drug Administration for continuing to combat misinformation about , misleading claims remain an unfortunate reality--especially related to interchangeability and safely switching from brand reference products to FDA-approved biosimilars.

America’s trade policy should reflect U.S. law and promote a balance between supporting the development of innovative medicines and promoting competition through greater access to and medicines. Unfortunately, U.S. trade has too often put the interests of pharmaceutical monopoly owners over the needs of the larger U.S. healthcare sector - such as the manufacturers of and . ℹ️ More info: https://www.accessiblemeds.org/advocacy/trade

With passage of the first and in 2012, Congress helped ensure the FDA would have sufficient resources to carry out its mission. Learn how over 10 years of the and program at the FDA have led to a dramatic increase in more affordable access to life-saving treatments for U.S. patients:

GDUFA/BsUFA User Fees Explained What are GDUFA/BsUFA user fees? Watch this video to learn more about how the Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Act (BsUFA) hel...

“Middlemen have outsized influence on US drug prices, FTC says”
Yahoo News
Reuters

Middlemen have outsized influence on US drug prices, FTC says WASHINGTON (Reuters) -The consolidation of pharmacies and health insurance companies through years of dealmaking has led to a handful of pharmacy benefit managers exercising outsized influence over prescription drug prices, the U.S. Federal Trade Commission said on Tuesday. The FTC argues the three....

Curious about medicines? Find answers to commonly asked questions aboutthese critical, lower-cost treatment options: https://biosimilarsresources.org/resource/faqs/

APhA has created two brand-new resources on biosimilars with pharmacists in mind. Elevate your expertise and expand your knowledge of interchangeable biosimilars with these expertly crafted educational materials.

To learn more about these free tools, check out the APhA biosimilars webpage at https://ow.ly/N3qn50SpunR today.

From
Pharma Manufacturing:

“FDA shares updated draft guidance on biosim interchangeability

The updated, “Considerations for Demonstrating Interchangeability with a Reference Product: Update,” draft guidance suggests that applicants may not always need to conduct extensive switching studies to demonstrate interchangeability.”

More⬇️

FDA shares updated draft guidance on biosim interchangeability The new guidance suggests that switching studies would not be necessary to demonstrate interchangeability

An interchangeable designation is unique to the U.S., and is not an indication of superior quality. In reality, this designation allows a pharmacist, subject to state law, to substitute and dispense a biosimilar when a patient’s doctor has prescribed the reference biologic. WATCH to learn about , , and how can help to increase to critical medicines at a lower cost! ▶️

Interchangeability 101 - Biosimilars & Interchangeable Biologics Follow along with this simple, animated white board video to learn about biosimilars, biologics, and how interchangeability can help to increase patient acce...

Biosimilars Council Applauds Updated FDA Guidance on Interchangeability

READ MORE in TODAY'S NEWS RELEASE>>>
Association for Accessible Medicines
U.S. Food and Drug Administration

Biosimilars Council Applauds Updated FDA Guidance on Interchangeability — Biosimilars Council The Biosimilars Council applauds the FDA for updated draft guidance released on June 20, 2024—regarding switching studies intended to support biosimilar medicines.

FDA-approved are alternatives to reference – much like generic drugs – providing more affordable treatment options for patients who need biologic medicines to manage their conditions. The Biosimilars Council, a division of Association for Accessible Medicines, wants to spread the word about access to critical, lower-cost treatments. Find resources to help answer your questions and learn more about biosimilars, here:

Home | Biosimilars | Patient Resource Center | Biosimilar Medicines Biosimilar medicines give 1.2 million patients in the United States access to life-changing results. Learn more about these medicines.

Around 80 percent of currently do not have a product in the works. Let’s reduce that percentage and pave the way for a new generation of lower-cost medications. READ MORE in new Biosimilars Council position paper, here: https://biosimilarscouncil.org/resource/streamlining-the-development-of-biosimilar-medicines/

"For the first time, the FDA recently asked Congress to end a legal distinction between biosimilar products and interchangeable products, arguing that the distinction is effectively meaningless and leads to consumer confusion."

Read More from Politico's Agency IQ:
https://www.agencyiq.com/blog/the-fda-wants-to-kill-the-interchangeable-biosimilar-its-not-waiting-on-congress-to-start-the-burial-preparations/
Association for Accessible Medicines
POLITICO

Streamlining the regulatory considerations for critical biosimilar medicines is a way to get safe and effective treatment options to patients more quickly, using robust scientific tools and advanced analytical methodology to identify clinically meaningful differences.

Benefits of a more efficient process are plentiful and include:
✅ Increased availability of lower-cost, safe and effective treatment options for patients—all while reducing patient exposure to clinical studies that will not contribute to the regulatory decision-making process.
✅ Allows industry leaders to make a greater impact through research and development investments.
✅ Allows the FDA to engage more efficiently with the industry—while reducing their review process timeline.

Learn More: https://biosimilarscouncil.org/news/biosimilars-council-calls-efficient-regulatory-pathways-critical-medicines/

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The Festival of Biologics brings together pharma and biotech, academics and research institutes, together with their partners across the value chain. The event focuses on the discovery, development, manufacturing, pricing and market access, clinical trials, and commercialization of biological drugs.

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