New guidance on generic opioids, biosimilars labeling coming from FDAFDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.
Humira biosimilar demonstrates positive results for rheumatoid arthritisAmgen has announced positive results from a clinical study evaluating the safety and efficacy of biosimilar candidate, ABP 501, compared with Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis.
Adoption of fast-growing biosimilars segment essentialGiven the spending growth projections for biologics, successful managed care organizations must find a way to ensure appropriate adoption of biosimilars, according to a study published in Health Affairs’ February issue.
[BLOG]: Biosimilar confusion and insightsSince Virginia became the first state in May 2013 to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug, there has not been much activity or clarity on the issue.
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.