The Food and Drug Administration (FDA) has released its lists of approved biosimilar licensed products, called the “Purple Book”. The invaluable site includes the date a biological product was licensed under the PHS Act and whether FDA evaluated the biological product for reference product exclusivity.
Recently, state legislators in Colorado passed a biosimilars bill that would allow pharmacists to substitute a biosimilar drug for name-brand biologics in cases where the FDA has declared the drugs interchangeable.
In this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.
FDA's approval of the “generic" biologic prescription version of cancer medicine Neupogen opens the door to a movement that could save the US healthcare system tens of billions of dollars a year, according to Forbes.
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.