The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.
The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines. The paper sets out the EAHP’s position on a number of issues related to biosimilar usage:
The organization’s position contains marked contrasts to current thinking about biosimilars in the United States. First, the FDA calls for a biosimilar to bear both a nonproprietary name that includes an FDA-designated suffix, devoid of meaning, that will distinguish products from one another. The FDA says that this approach will help to prevent inadvertent substitution of products. It is also considering an approach to suffix formats that will designate interchangeable products.
The FDA’s guidance also differs from EAHP’s position in terms of interchangeability; the FDA’s “Considerations in Demonstrating Interchangeability With a Reference Product” draft guidance indicates that robust data, including switching studies that include at least 3 switches between biosimilar candidates and reference products, will be required before a designation of interchangeability will be granted to a biosimilar product.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.