FDA issues biosimilar final guidanceFDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
FDA releases final guidance documents on biosimilarsThe FDA issued three final guidance documents on biosimilars for pharmaceutical manufacturers and others in late April.
Patent litigation could hold up biosimilarsEleven of the most promising biosimilars will create an estimated $250 billion in savings for U.S. payers, according to pharmacy benefits manager Express Scripts.
Biosimilars’ cost savings unknownThe pharmaceutical and healthcare industry is lauding the FDA’s approval of the first biosimilar product this year, noting that the drugs could save the U.S. healthcare system billions of dollars.
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.