3 briefs
A biosimilar approved in 2016. Still shelved in 2026.
Sandoz's Erelzi received FDA approval in August 2016. Nearly a decade later, it still hasn't launched in the US - while the same drug has been selling in Europe since 2017. The patent cliff is set for 2029. An antitrust challenge was dismissed in February 2026 and is now on appeal.
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.
The difference explains everything about how biologics compete.
When a small-molecule patent expires, generics arrive at 90% off. When a biologic patent expires, biosimilars arrive years later at a modest discount. Same industry, completely different economics. The reason is molecular.
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