Humira Biosimilar Interchangeability: The Race Begins
Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.
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Samsung’s Renflexis: Second US Biosimilar To Janssen’s Remicade, With A Few Firsts
Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.
Humira's Inevitable Decline: What's Waiting In The Wings?
There are 20 biosimilar adalimumab drugs in development – including one from Amgen that has already been approved but not yet launched. Biotechs and big pharma companies alike are lining up their candidates in preparation for when AbbVie's world-leading inflammation and immunology product Humira loses patent protection.
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.