FDA rejects Coherus’ reworked Neulasta biosimilar due to third-party inspections

The FDA has re­ject­ed Co­herus Bio­Sciences’ new pre­sen­ta­tion for its Udeny­ca (peg­fil­gras­tim-cbqv) biosim­i­lar due to an in­spec­tion at one of its con­trac­tors.

Co­herus said the BLA for its up­dat­ed biosim­i­lar to Am­gen’s Neu­las­ta was re­ject­ed due to on­go­ing in­spec­tion prob­lems at this un­named third par­ty.

But no is­sues were found with this new Udeny­ca biosim­i­lar’s clin­i­cal tri­als, drug ef­fi­ca­cy, safe­ty, la­bel­ing or man­u­fac­tur­ing, the com­pa­ny said in a press re­lease. Co­herus is work­ing close­ly with the FDA and third par­ty to bring the drug to ap­proval as quick­ly as pos­si­ble.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.