How pharmacists can keep up with biosimilar approvalsThe 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.
FDA’s First Biosimilar Approval Draws Excitement, ConcernThe FDA has approved filgrastim-sndz (Zarxio, Sandoz), treating patients at increased risk of neutropenia, but it's stirring up mixed emotions. Learn why
States grappling with biosimilar substitution lawsRecently, 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.
[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patientsIn 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.
Biosimilar drugs could save US billionsFDA'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 approves first biosimiar ZarxioFDA approved filgrastim-sndz (Zarxio, Sandoz), the first biosimilar product approved in the United States.
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.