Biosimilars Newsfeed
Biosimilars in Development Near End of Phase 3 Trials
Managed Care (02/01/16) Adams, Katherine T.
Results from a head-to-head Phase 3 study indicate that Amgen's biosimilar candidate ABP501 is comparable to AbbVie's adalimumab (Humira) for patients with moderate to severe plaque psoriasis. The study met its primary endpoint of improvement in Psoriasis Area and Severity Index (PASI) from baseline to Week 24. Amgen is also developing biosimilars of cetuximab (Erbitux) and bevacizumab (Avastin). Amgen's etanercept (Enbrel) is also the target of biosimilar development. A 52-week study of CHS0214, conducted by Coherus, demonstrated PASI-75 equivalence at 12 weeks for the treatment of moderate to severe plaque psoriasis. The ongoing trial is measuring mean percent change from baseline and the proportion of subjects achieving 75 percent improvement in PASI in patients given CHS0214 compared with those given etanercept. Meanwhile, Novartis is waiting for approval from the Food and Drug Administration for a long-acting treatment for boosting white blood cell count, a biosimilar of Amgen's pegfilgrastim (Neulasta). This is Novartis' third biosimilar submission, and it expects to make 10 more filings over the next three years.
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