Interchangeability In Biosimilars
Maia Kayal, MD, MS, defines interchangeability and reviews the requirements from the FDA, "switching studies," and meaningful difference verses class effect.
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Maia Kayal, MD, MS, defines interchangeability and reviews the requirements from the FDA, "switching studies," and meaningful difference verses class effect.
Kimberly C. Chen DO, MSHLM, and Maia Kayal, MD, MS, review the challenges related to biosimilars from the payer perspective and strategies payers may employ to help improve the uptake of biosimilars.
Jonathan Kay, MD, discusses challenges that patients may experience related to biosimilars for inflammatory conditions
Jonathan Kay, MD, and Kimberly C. Chen DO, MSHLM, define what a biosimilar is and discuss the potential for a lower cost than the reference product.
As one BPCIA case came to a close in May, another got underway. On May 1, 2023, Amgen filed a complaint in the District of New Jersey, accusing Sandoz of infringing patents that relate...