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Latest From Becton, Dickinson and Company

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

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Two BLAs, One Suffix: FDA Diverges From Nonproprietary Naming Guidance For Amgen’s Wezlana

Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen’s ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance.

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Wezlana Chronology: From Biosimilar To Interchangeable In The Blink Of An Eye

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssen’s Stelara.

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Finance Watch: Frontier Raises $80m For Differentiated KRAS G12C Program

Private Company Edition: With its lead program in the clinic, Frontier’s $80m series C round will fund trials for additional programs. Also, ORI raises $260m for second fund, Earlybird closed a €173m ($187.1m) fund, Areteia’s series A grew to $425m and Sudo’s series B increased to $147m.

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