This will be a mega-blockbuster (add-on to) overall revenue for Merck. But it will only nudge the needle a bit, on the ~$65 billion a year Merck grosses. [Certainly -- after 2028, as the infused version begins to see patent expiries around the globe, the subcutaneous version will cannibalize some of the overall sales, to preserve them.] Still, it is welcome (if mostly expected) good news:
. . .The FDA has approved Merck & Co.’s under-the-skin version of Keytruda, reducing treatment time burden for patients while granting the world’s bestselling drug potential blockbuster revenue protection.
Friday’s approval for Merck’s Keytruda Qlex covers the solid tumor indications approved for the original intravenous formulation of Keytruda, according to the FDA.
With $8 billion in sales for the second quarter, Keytruda accounted for more than half of Merck’s total revenue during the period. As infused Keytruda is slated to lose patent protection in 2028, the subcutaneous formulation will be critical to the New Jersey pharma’s top-line stability. . . .
Fierce Pharma is -- as ever -- right about all of this, but it is also why I've long said the 2028 "cliff" is more a small speed bump, than a cliff of any sort. Onward.
नमस्ते







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