Fresenius Kabi Awaits EMA Inspection For Pegfilgrastim Biosimilar
Facing Greater Challenge For FDA Approval
Having recently announced plans to launch a further four biosimilar products in the next four years, Fresenius Kabi has disclosed the latest on its bid to introduce pegfilgrastim, which has been hamstrung in the US by delayed inspections.
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Fresenius Kabi is pressing on with its ‘Vision 2026’ strategic growth initiatives, with the company wrapping up its acquisition of Insud Pharma’s bio unit mAbxience. However, it remains “to some degree output constrained,” which looks set to continue to impact operations, amid staff shortages.
Positive CHMP opinions recommending European marketing authorizations have been granted for Accord’s teriparatide and Fresenius Kabi’s pegfilgrastim biosimilars, while the sponsor for an ophthalmic version of bevacizumab has asked the EMA to take a second look at the rejection of its application. Three Accord generics were also endorsed by the CHMP at its January meeting.
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.