Preliminary Phase 3 Study Data Looking Good for Amgen’s Ustekinumab Biosimilar

Amgen announced on April 18 that its 563-patient study of ABP 654’s efficacy and safety is not demonstrating any clinically meaningful differences compared with the reference product Stelara® in moderate-to-severe plaque psoriasis. The study completion date is scheduled for early June 2022, whereas a multiswitch study is scheduled for completion March 2023.

Based on the confirmation of the successful noninferiority results, Amgen may file for approval with the FDA as early as Q4 of this year, which could result in an FDA decision in late 2023. This would put Amgen’s ABP 654 on roughly the same track as Formycon’s FYB202 and Celltrion’s CT-P43 as they vie for first biosimilar launch in the $6 billion US Stelara market. The principal Stelara patent expires in September 2023.

In other biosimilar news…Amgen has emerged with a patent victory for its branded product Neupogen®. The US Court of Appeals has rendered its decision in an old case, involving a Patent Trial and Appeal Board (PTAB) judgment in favor of Apotex. However, Apotex long ago gave up on its quest to bring a filgrastim biosimilar to the US market.

Hopefully, the confusion over the identity of Viatris’ insulin glargine biosimilars won’t become a real issue. The company announced a recall of one batch of its unbranded insulin glargine (insulin glargine-yfgn) 100 U/mL injection, because of missing drug labels on some vials. Since Semglee® also carries the same -yfgn designation, this could be a source of some questions. The recall does not involve Semglee® vials, only the authorized biosimilar form, according to Viatris.

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