biosimilars

Cancer biosimilar drug deemed similar to NeupogenNovartis AG’s biosimilar cancer drug, EP2006, is “highly similar” to Amgen’s blockbuster cancer drug, Neupogen, FDA staff said in a new report.
NCPA opposes Penn. biosimilar bill as too costlyThe National Community Pharmacists Association (NCPA) strongly opposes a Pennsylvania bill that would only allow biosimilar substitution by a pharmacy with permission of the prescriber.
Will the pathway to approval of biosimilars run smoothly?As of July 24, Sandoz became the first to file for approval of a biologic under the biosimilar pathway. What will happen next remains to be seen.
AbbVie acquires Shire amid looming Humira biosimilar competitionThe AbbVie purchase of Shire for about $54 billion will create one of the biggest deals so far this year.
AMCP: Clarity on guidelines stalls biosimilars’ debutFDA is slowly implementing draft guidelines for bringing biosimilars to market, while states are enacting laws requiring additional notification and record keeping for the products
AMCP: Expect billions in cost savings from biosimilars in 3 yearsIn 2014 and beyond, pharmacy leaders should watch for more oral drugs and more expanded indications of specialty drugs.
PODCAST: Advances in psoriasis treatmentThe past few years have been an exciting time for those who treat psoriasis and for many patients with severe disease because of excellent new therapies for this often intractable problem. Norman Levine, M.D., talks with Alan Menter, M.D., Baylor University Medical Center, Dallas, about recent developments in the treatment of psoriasis.
Sandoz to test biosimilar for adalimumabSandoz has begun a phase 3 trial of a biosimilar version of adalimumab (Humira, AbbVie) for moderate-to-severe plaque psoriasis.
California governor vetoes biosimilar substitution billWith pharmacy industry bodies, labor unions, and special interest groups arrayed against the bill, Governor Brown returned the legislation to the State Senate unsigned.
Preparing for biosimilarsA short history of biologics and biosimilars, with some pointers on what comes next