An aspiring biosimilar manufacturer is employing a citizen’s petition in a novel way in hopes of setting regulatory approval standards. In a May 3 letter, Apotex asked the Food and Drug Administration to set a specific requirement for other biosimilar companies that, depending upon what the agency decides, may serve as a barrier to regulatory approval of their treatments.
Here’s the back story: Apotex is seeking FDA approval to sell a biosimilar version of Neulasta, a drug sold by Amgen that notched $3.9 billion in sales in the US last year and helps cancer patients on chemotherapy fight infections. However, an erstwhile rival called Coherus last year released a statement indicating its own application for a biosimilar version evaluated the clinical effect only in healthy patients.
A trial in healthy patients? REALLY? What are the inclusion/exclusion criteria to NOT end with an empty cohort? 🙂
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