11 min read
Why FDA Approval Isn't the Moment Biosimilars Start Competing
Lessons from Humira.
Amgen got FDA approval for Amjevita in September 2016. It shipped its first US vial in January 2023. Six and a half years between approval and market entry - and nine more Humira biosimilars followed the same pattern. The gap between "approved" and "on sale" isn't a quirk of Humira. It's how biologics competition works.