Jul. 4 at 4:05 PM
$ATNM"The Complete Biosimilar Forcing Function — Every ICI Under Threat
Pembrolizumab's anticipated 2028 loss of exclusivity highlights the need for pharmacists to prepare for biosimilar market entries, with regulatory submissions to the FDA occurring as early as 2026 or 2027.
Nivolumab's key patent in the US is set to expire in 2027, while in Europe it will likely expire earlier in 2026, with biosimilar manufacturers including Amgen and Sandoz attempting to capture market share.
Opdivo is Bristol-Myers Squibb's top-selling cancer drug with sales reaching
$9.3 billion in 2024, with its composition of matter patent set to expire in the US in 2027 and in the EU in 2026.
Despite label expansion and potential novel combination therapies, Opdivo's growth will be threatened by patent expiry in 2026 in the EU and 2028 in the US, resulting in a predicted drop in total annual sales to
$1.8 billion by 2029 for branded nivolumab.
This is the complete picture that every acquirer's CFO is"
