All potential drugs go through rigorous safety assessments during their development – and so do their names. Selecting a drug name can take years.
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Merck & Co. is swinging a double-edged sword with this week’s launch of Keytruda Qlex, a subcutaneous version of its longtime cancer blockbuster. On the one hand, the quicker administration with no significant difference in efficacy offers patients an in-and-out regimen they couldn’t get from the infusion chair. On the other hand, the new shot is set to cost the same as the original, so the company is nullifying the markdown effects of biosimilar entry by squeaking a modified recipe into the market just before a patent expiration. Influential lawmakers like Elizabeth Warren and Bernie Sanders made the cost point a couple years back.
While turning a biologic like Keytruda into a minute-long shot under the skin is a huge achievement that will undoubtedly change the paradigm for cancer patients, it also games a system designed to allow drug costs to fall over time. And although Merck’s efforts to keep the revenue stream flowing don’t constitute the kind of “patent thicket” that kept drugs like AbbVie’s Humira from bowing to biosimilars for years, the strategy is similarly likely to prevent biosimilars from making a dent in the overall healthcare spend as the law intended.
For Merck, the new Keytruda delivery is a clear win. With the cancer immunotherapy comprising about half of the pharma giant’s sales revenue last year, the company needs to soften the patent loss blow, and Keytruda Qlex is a way to do that. Today, we’re exploring the impact of the subcutaneous cancer shot and what it means for a company on the brink of a patent crisis.
Thanks for reading.
Michael Gibney Senior Editor & Writer, PharmaVoice Email
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