USA-based Coherus BioSciences (Nasdaq: CHRS) lost 24.5% of its value on Monday after receiving a complete response letter (CRL) from the US Food and Drug Administration (FDA) relating to its biosimilar version of Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim).
It was welcome news for Amgen on a day when the US biotech major saw the Supreme Court rule against its argument that biosimilar manufacturers should be forced to delay their 180-day marketing notices until after the FDA has approved their marketing applications.
"Neulasta is the largest-selling oncology biologic in the USA, and we anticipate CHS-1701’s approval will generate significant healthcare savings while increasing access"
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