New Biosimilars Council Head Seeks Insulin Lessons As More Biosimilar Launches Loom
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.
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David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person to run the association since February 2020.
A further voluntary recall for Viatris’ insulin glargine biosimilar, this time for one of its recently launched interchangeable products, because of missing labels may draw unwanted interest from the US FDA, a leading analyst has warned.
2022 will be an important year for biosimilar manufacturers as the market expands into new areas like ophthalmology and insulin, and as the Humira US biosimilar entry nears in 2023.