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in terms of interchangeability; the FDA’s “Considerations in Demonstrating Interchangeability With a Reference Product” draft guidance indicates that robust data, including switching studies that include at least 3 switches between biosimilar candidates and reference products, will be required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.
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