A Note from Biosimilars Council Executive Director Christine Simmon
As we close out Women’s History Month, I would like to extend my sincere gratitude to all the women who have helped grow our industry, many of whom we showcased in our #GRxBiosimsWomen social media campaign. Your tireless efforts have made an invaluable contribution to biosimilar adoption and more affordable drug pricing. I am proud to call many of you both my colleagues and my friends, and I look forward to the path ahead as we work to continue expanding access to biosimilar medicines.
This month the Biosimilars Council was encouraged that Congress began the process to reauthorize BsUFA. We look forward to working with policymakers and regulators to modernize the biosimilar review process and set the stage for greater access to lower-cost options for patients.
Finally, AAM’s VP of Policy Craig Burton represented the Biosimilars Council at the Festival of Biologics in San Diego. Craig spoke on the opening keynote panel, and highlighted policy options to increase biosimilar adoption.
With all that took place this past month, I was once again reminded how fortunate we are to work in the biosimilars industry for a cause that is leaving a positive impact on our health care system and for the patients relying on these life-saving medicines.
News & Updates
Industry Seeks Clean User Fee Reauthorization as Lawmakers Eye Riders
David Gaugh, senior vice president for sciences and regulatory affairs at AAM, said the group and its Biosimilar Council “strongly support timely congressional reauthorization of the user fee agreements.” He added that the Generic Drug User Fee Amendments (GDUFA III) and the Biosimilar User Fee Amendments (BsUFA III) “are the culmination of months of negotiation, have been subject to public review and comment and represent a careful balance between all stakeholders.”
Expert: ‘Pharmacists Should Have a Role at the Table’ When Payer or Drug Availability Challenges Arise
Pharmacy Times interviewed Shannon Hough, director of ClinReview in Clinical Content for McKesson, on the growing shift to biosimilars in oncology, which is impacting patients and practices by reducing the financial burden of oncology treatments and increasing access to therapies, resulting in greater medication adherence.
Drug Pricing Reforms Should Focus on Expanding Choice, Not Imposing More Government Controls
Competitors to originator biologics exist (i.e., biosimilars) that are just as clinically efficacious and 40% to 60% less expensive than the originators. However, far too many drug formularies place biosimilars on worse tiers, denying patients the opportunity to use these medicines. As a result, the formulary restrictions reduce patient choice and force patients to pay higher costs.
BsUFA Reauthorization and Modernization Is the Key to a Healthy Biosimilar Market
The Biosimilar User Fee Act, or BsUFA, will include a commitment by biosimilar manufacturers to pay fees that support the FDA’s review of biosimilars, as well as other regulatory activities. For example, BsUFA fees accounted for 60% of total program costs in 2020, and it is critical that a reauthorization is signed into law before the end of the year, when the current funding agreement expires.
Drug Pricing Woes Linger as Medicare Mulls Point-of-Sale Changes
Manufacturer rebates “artificially increase the negotiated price of drugs in the Medicare program,” Christine Simmon, senior vice president of policy and strategic alliances at the Association for Accessible Medicines, told the Medicare agency. The proposal is a step in the right direction, but “additional work remains to remove harmful distortions in the Part D Program,” Simmon wrote in a comment letter.
Roy Fleischmann, MD: History and Implementation of Biosimilars in Rheumatology
As a part of our biosimilars series, Rheumatology Network interviewed Roy Fleischmann, MD, to discuss the history of biosimilars as well as his thoughts on implementing biosimilars in the United States. Fleischmann is Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas and co-Medical Director of the Metroplex Clinical Research Center in Dallas.
Treating Ulcerative Colitis, and Enjoying a Slice or Two
Greg, 37, of Los Angeles, CA., spends most of his time hiking, running and lifting weights, but his greatest passion in life is pizza. Not long ago, he made a bet with his wife that he could eat pizza and nothing but pizza for 45 days. As if that weren’t unusual enough, you should know that Greg has a history of ulcerative colitis.
Singing, Dancing and Taking Care of Herself with Biosimilars
Eileen, 28, lives in New York City and is pursuing her dream of a career in musical theater. Her stage credits keep growing, and thanks to her biosimilar medication, her Crohn’s disease isn’t getting in the way.
GRx+Biosims 2022 – November 7-9, 2022
GRx+Biosims 2022 is the premier scientific and regulatory event for the U.S. generics and biosimilars industry, featuring timely programming relevant to technical, regulatory and 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. Register Now.
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