Biosimilars Bulletin | June 2022

Monday July 25, 2022

A Note from Biosimilars Council Executive Director Craig Burton

This month, both chambers of Congress made progress in advancing legislation to reauthorize the Biosimilar User Fee Act (BsUFA), with the House of Representatives passing its bill, and the Senate HELP Committee approving its version for the full Senate’s consideration. This legislation is critical to the future of patient access to biosimilars and provides the U.S. Food and Drug Administration (FDA) with the resources it needs to review new biosimilar products. Over the years, the Biosimilars Council has played a leading role in collaborating with the agency and other stakeholders on this legislation and the underlying provisions, and we will continue our work to ensure that this legislation is signed into law before the September 30 expiration.

In addition, there continues to be a high degree of energy and interest in addressing the perverse incentives and PBM behavior favoring high-cost brand drugs over lower cost products, including biosimilars. The FTC released an important policy enforcement statement emphasizing that “when dominant drug manufacturers or intermediaries stifle or foreclose competition from significantly less expensive generic and biosimilar alternatives, the Commission has the legal authority to investigate these practices and take enforcement action against unlawful conduct.”

Finally, a big thank you to the many of you who shared your input about the new Biosimilar Council’s new Biosimilars Patient Resource Center. We have been encouraged by the positive reception of the resource center, and we appreciate your interest and ideas as we continue to improve this important resource for patients.

– Craig Burton

News & Updates

AAM: Biosimilars Council launches Patient Resource Center 

The Biosimilars Council has launched the Biosimilars Patient Resource Center to close the biosimilars knowledge gap and to promote public awareness and trust of biosimilars. We will promote the resource in partnership with allies and stakeholders through social media, blogs and advertising.

Consulting With Clinical Pharmacists May Help Boost Biosimilar Adoption 

Consultation visits with a clinical pharmacist prior to one with a rheumatologist was found to significantly increase the number of patients who opted for a biosimilar over a reference product, according to a retrospective analysis.

Competition Intensifies As Access Increases For US Biosimilars 

With new ground continuing to be broken in US biosimilars – including most recently the launch of the first rival to Lucentis (ranibizumab) by Samsung Bioepis and Biogen – the industry is expecting even bigger things to come in 2023, as the arrival of multi-source competition to Humira (adalimumab) grows ever closer.

Promote Regulatory Certainty By Reauthorizing UFA 

This week, the Senate HELP Committee passed the Senate version, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, a reauthorization of Prescription Drug User Fee Act (PDUFA), the Biosimilars User Fee Act (BsUFA), and the Generic Drug User Fee Amendments (GDUFA). These UFA programs are widely recognized as cooperative success stories that fundamentally improve patient outcomes. Consequently, these Acts deserve swift reauthorization, which must be done every five years, without the baggage that may come from any unrelated policy issues.

Pediatric Research: More Education About Biosimilars is Needed for Providers and Families 

Biosimilars increase market competition and drive down health care costs overall. By opening the door to conversation and education, families who could benefit from switching to a biosimilar may have improved perceptions about the effectiveness of the therapy.

Industry Hails Access Implications As FTC Promises PBM Probe 

The US FTC’s announcement of an inquiry into PBMs will be music to the ears of the country’s generics and biosimilars industry, which has long called for action on abusive practices that undermine access.

House Passes FDA Package Reauthorizing Drug, Device User Fees

The House on Wednesday passed a sweeping package to reauthorize the fees that help fund the FDA as the Senate works to pass its own version of the bipartisan legislation. House members voted 392-28 under suspension of the rules to pass the legislation (H.R. 7667).

Lowering Patient Drug Costs with Biosimilars Can Happen When the Right Teams Come Together 

We see a great deal of opportunity to obtain market-leading savings for clients that begin to adopt biosimilars and lower net cost options rather than high-cost reference brand biologics, which can in turn help hold down premium costs for members. And in the last year, we’ve begun to see biosimilar use increase in the oncology and autoimmune categories.

Featured Resources

Biosimilars Patient Resource Center

Everything You Need to Know About Biosimilars – All in One Place 

The Biosimilars Council launched the Biosimilars Patient Resource Center to help answer those questions and educate patients and consumers about these important, lower-cost treatment options. Visitors of the Patient Resource Center will find infographics, patient testimonials, fact sheets and helpful links from the Biosimilars Council, the FDA and other stakeholder groups, in addition to answers to frequently asked questions. Also, visitors can register for an “Introduction to Biosimilars” email series, which gives a crash-course on key facts about biosimilars that patients need to know.

Biosimilars Policy

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) help to get more generic and biosimilar medicines to patients more quickly. Over ten years, the generic and biosimilar industry has provided the FDA over $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $2 trillion in savings to patients and a dramatic increase in patient access to life-saving treatments.

The Basics of Biosimilars for Oncology Nurses 

As biosimilars continue to be approved for cancer-specific agents, the role of the oncology nurse in implementing and educating patients about their use becomes more pronounced, according to Kellie Zeichner, RN, BSN, OCN. In the discussion, Zeichner highlighted the vital components of the development of biosimilars and interchangeable products that oncology nurses need to know.

Events

IGBA—MOPI Conference 2022 

The conference will provide a great opportunity for participants from the Global, and especially Southeast Asian, off-patent pharmaceutical sector to finally meet again in-person. It will offer a unique chance to address the challenges highlighted by the pandemic as well as the strength and value of this industry. It will also address the local and international policies needed for generic, biosimilar and value-added medicines to become central to global healthcare. Learn More.

GRx+Biosims 2022 

GRx+Biosims 2022 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries featuring timely programming relevant to technical, regulatory, policy professionals. Top officials and subject matter experts share their knowledge and best practices to enhance attendees’ understanding of how to succeed in generic and biosimilar development, regulatory process and approvals, and the evolving policy landscape. Learn more.

Global Biosimilars Week 2022 

The International Generics and Biosimilars Medicines Association (IGBA) is hosting its third annual Global Biosimilars Week. This event raises awareness of the powerful impact of biosimilar medicines and provide key resources for advocates and interested parties. This year’s theme is, “Strengthening Healthcare – the Value of Biosimilar Medicines.” Learn More and download the social toolkit.

Access! 2023 – AAM Annual Meeting

Save the Date! Meet the leaders and decision-makers who are shaping the future of generics and biosimilars. Be inspired by new experiences, real talk and fresh ideas during a period of intense challenges and exciting promise. Join generic and biosimilar industry professionals at Access! 2023. Learn more.

Want to hear directly from Executive Director Craig Burton?

Follow him on LinkedIn

Interested in joining the Biosimilars Council?

Contact Jewel Smith ([email protected]org) for more information.

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Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:

Register Now! November 7-9 | North Bethesda, MD

GRx+Biosims is the premier scientific and regulatory event for the generics and biosimilars industry. This year’s conference will be held in-person for the first time since 2019!