Coherus BioSciences, Inc.
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Latest From Coherus BioSciences, Inc.
“Innovating cancer care for patients is a winning strategy,” Coherus said as it delivered on the first US biosimilar version of Amgen’s dominant pegfilgrastim formulation, using an on-body device to deliver the medication, months after a protracted FDA approval.
Sandoz has truly established its position as the frontrunner in the denosumab race after a Canadian approval, but the path to the US market has been hindered by a lawsuit from the originator Amgen.
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.
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- InteKrin Therapeutics, Inc.
- Coherus Intermediate Corp
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