Biosimilars Forum’s New Executive Director Faces Down Challenge Of Interchangeability Confusion
Juliana Reed, who just moved from Pfizer to head the trade group, hopes scientific advances will eventually eliminate the need for the interchangeability designation, but for now the association is educating stakeholders in preparation for the 2023 launch of Humira biosimilars.
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That’s So 15 Years Ago: Biosimilar Advocates Press US FDA, Sponsors To Evolve Thinking, Streamline Development
Requirements should adjust to scientific advancement, rather than remain rooted in times when the FDA and sponsors were inexperienced dealing with the products, sponsors argue.
Craig Burton, who replaces the FDLI-bound Christine Simmon, tells the Pink Sheet that fighting rebating practices which harm insulin patients now can pave the way for successful launches of Humira biosimilars next year. Biosimilar markets should not be ‘winner-take-all,’ he says.
Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.