To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.
As in the United States, there exist concerns in Europe about whether information on biosimilar product labeling is sufficient to meet the needs of end users—patients, pharmacists, and physicians—or whether changes to labeling are needed. To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium, on the topic of biosimilar labeling, and the results were recently published in the Generics and Biosimilars Initiative Journal.
The discussion focused on the perspectives of end users, and specifically on the Summary of Product Characteristics (SmPC), the Patient Leaflet (PL), and the immediate labeling on the outer product packaging. The workshop, sponsored by the European Biopharmaceutical Enterprises and the European Association for Bioindustries, was attended by 40 invited participants, including representatives of patients, physicians, pharmacist associations, academia, and industry. Representatives of the European Medicines Agency (EMA) attended the workshop by telephone as observers.
All stakeholders agreed on the need for better general understanding of the concept of biosimilarity, and also agreed that biosimilar labeling can be improved. Suggestions as to ways in which such labeling could be improved varied by stakeholder. Currently, once a biosimilar is approved for EU marketing, the EMA applies a same-label (generic) approach to biosimilar product labels, indicating that the information on the biosimilar’s labeling should be a copy of the approved labeling of the reference product (with the exception of the pharmaceutical particulars). The SmPC, which is not usually made available to patients, includes a statement declaring that the product is a biosimilar, but this is the only part of the labeling where this information can be found. Neither the PLs nor the immediate labels contain this information.
The stakeholders’ perspectives are summarized as follows:
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.