Reference Product News Today

On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product...

Nearly half (47%) of biosimilar users knew they were using biosimilars but 31% thought the medicine was an originator. In contrast, 80% of originator users knew they were using an originator, and none thought they were using a biosimilar.

Specialists define and discuss extrapolation, along with the importance of strong data in specific disease states.

Medical experts discuss interchangeability designation requirements for biosimilars.

Jonathan Kay, MD, and Kimberly C. Chen, DO, MSHLM, discuss clinical and financial concerns related to automatic substitution at the pharmacy for an interchangeable biosimilar from a payer perspective.

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...