The Top 5 Biosimilar Articles for the Week of November 28

Here are the top 5 biosimilar articles for the week of November 28, 2022.

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of November 28, 2022.

Number 5: After receiving FDA approval in February 2022, Amneal Pharmaeuticals and Kashiv Biosciences launched Releuko (filgrastim-ayow) on the US market, making it the fourth biosimilar referencing Neupogen to be commercially available to Americans.

Number 4: The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.

Number 3: A new bill dubbed the Biosimilar Red Tape Elimination Act was introduced to the Senate. The bill seeks to increase patient access to biosimilars by reducing switching study requirements for getting interchangeability designations, making it easier and cheaper for corporations to establish interchangeability and patients to obtain their biologic medications.

Number 2: The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).

Number 1: Iceland-based Alvotech received regulatory approval for AVT02, its biosimilar referencing Humira (adalimumab), from the Therapeutic Goods Administration of Australia.

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