Fresenius Delayed By FDA Inspection Uncertainty As It Works Towards US Pegfilgrastim Launch

Biosimilars Head Ali Ahmed Talks About Company’s Biosimilars Strategy

Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi, considers the launch of the firm’s proposed Neulasta (pegfilgrastim) biosimilar in the US “an important milestone for the company.” However, he explains in an exclusive interview with Generics Bulletin, delays to necessary FDA inspections are creating uncertainty for the firm over launch timing.

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Ahmed said the upcoming pegfilgrastim launch was “an important milestone for the company” • Source: Fresenius Kabi

“Pegfilgrastim is not just another launch, this is our entry into the US biosimilars market,” stated Ali Ahmed, senior vice president of US biosimilars at Fresenius Kabi, talking about the company’s plan to launch its proposed Neulasta biosimilar in the US. In an exclusive interview, Ahmed told Generics Bulletin that “we engaged with a lot of key stakeholders and they're very excited for Fresenius Kabi to enter into the biosimilar market in the US.”

Calling the launch “an important milestone for the company,” Ahmed said that the company is now expecting US Food and...

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