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Janssen Biotech Inc.

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Latest From Janssen Biotech Inc.

The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

‘We’re coming back,’ Oncology Center of Excellence Director Richard Pazdur says. Office of New Drugs Director Peter Stein says transition from virtual to in person will be gradual because FDA is trying to be sensitive to adcomm members' need to schedule travel and demands on their time.

Advisory Committees FDA

The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

‘We’re coming back,’ Oncology Center of Excellence Director Richard Pazdur says. Office of New Drugs Director Peter Stein says transition from virtual to in person will be gradual because FDA is trying to be sensitive to adcomm members' need to schedule travel and demands on their time.

Advisory Committees FDA

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.

Drug Review Profile Biosimilars

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.

Drug Review Profile Biosimilars
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