FDA’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.
Amgen 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.
Given 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.
Since 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.