Policy

Julie M. Reed, the executive director of the Biosimilars Forum, discusses how biosimilar savings can differ between stakeholders and the importance of competition for creating those savings.

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the real-world patterns of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.

A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.

Amy Valley, vice president of clinical strategy and technology solutions at Cardinal Health, details the company's Decision Pathway, a health information technology (IT) tool that can assist practices with prescribing patients the lowest-cost product, including biosimilars.

Biosimilar manufacturers should consider working together to overcome some of the barriers that prevent biosimilars from entering the market and obtaining market share, according to Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board.

A report on biosimilar uptake and existing policies signals that policy makers should proceed with caution when establishing new policies to boost biosimilar utilization and savings, as many patients and providers still have concerns on their usage.

Stacie B. Dusetzina, PhD, is the Ingram Associate Professor of Cancer Research at Vanderbilt University Medical Center, and a member of the editorial board for The American Journal of Managed Care®.

The main takeaway from the House Energy and Commerce Committee hearing on HHS's 2023 budget was that biosimilars were not mentioned as much as they should have been, said Julie M. Reed of the Biosimilars Forum.

Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System, discusses the importance of state legislation to boost biosimilar access and uptake.

Now that the United States’ acceptance of biosimilars matches that in the European Union, developers should be encouraging changes to testing regulations to increase biosimilar accessibility, according to Sarfaraz K. Niazi, PhD, in his recent perspective paper.

Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.

Medicare Part D plans missed out on between $84 million and $143 million in savings by not prioritizing the use of biosimilars over reference products, according to a report from the HHS Office of Inspector General.

Edward Arrowsmith, MD, discussed his recent paper on the use of clinical pathways for specific cancer types and how biosimilar development can help ensure quality of care for patients with limited therapeutic options.

The executive director of the Biosimilars Forum calls for policies to support adoption of lower-cost biologics.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, previews his sessions about the new and emerging pharmaceutical products coming down the pipeline at the upcoming Academy of Managed Care Pharmacy (AMCP) annual meeting.

As HHS prepares to begin a study that will summarize the use and spending of biosimilars within Medicare Part B plans, the FDA updates its clinical trial guidance to expand enrollment access to senior patients.

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, reviews some of the presentations, including her own, from the Festival of Biologics conference.

The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.

A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.

There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, according to executives who gathered last week during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.

Purva Rawal, PhD, senior advisor and chief strategy officer, Center for Medicare and Medicaid Innovation, spoke during the Association for Accessible Medicines' Access! annual meeting, which gathered in Orlando, Florida, February 15-16.

A panel of experts details the current concerns regarding interchangeability designations for biosimilars in the United States and calls for regulators and policy makers to make changes to allow to easier access to biosimilars and greater adoption.

Improving access and getting big legislative changes for biosimilars passed are just some of the many plans that Julie M. Reed, the new executive director of the Biosimilars Forum, has for the organization.

The IGBA maintains dialogue with other national, regional, and international bodies to ensure patient access to high-quality, safe, and effective medicines while reducing costs in pharmaceutical care.

Julie M. Reed, the new executive director of the Biosimilars Forum, gives a timeline of her career in the biosimilars space and what led her to be one of the founders of the organization.

The province is the latest jurisdiction to adopt a program that will require patients to switch away from expensive reference biologics to select biosimilars for certain conditions.

The non-profit organization dedicated to the advancement of biosimilars has appointed Cofounder and President Juliana (Julie) M. Reed, as the new executive director. Reed shared some of her goals for the Biosimilars Forum in an interview with The Center for Biosimilars®.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, discusses how to ensure affordability of adalimumab biosimilars when they enter the market as AbbVie continues to raise the price of the reference product (Humira).

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, talks about what kind of educational material still needs to be created and which stakeholders are in need of education on the financial benefits of biosimilars.