FDA approval of biosimilars

Will biosimilars deliver on expectations?
Will biosimilars deliver on expectations?This might be the year when it becomes clear, perhaps painfully so, whether or not biosimilars can deliver on cost savings expectations.
Samsung Gets First U.S. ApprovalThe second Remicade biosimilar is only the fifth biosimilar approved in the United States.
FDA approvals for specialty drugs to pick up in 2017Numerous specialty medications, generics, and biosimilars, are expected to be approved this year for cancer, inflammatory and autoimmune diseases, and other indications.
Why pharmacists are concerned about the safety of biosimilarsPharmacists and other healthcare professionals are looking to the FDA for more guidance on biosimilars and interchangeability with their reference products.
Biosimilar approvals deemed “too slow”While FDA’s approval last week of infliximab-dyyb (Inflectra, Celltrion and Hospira), a biosimilar to Remicade (Janssen Biotech) for rheumatoid arthritis, Chron’s disease and other conditions is positive, FDA’s approval pace for biosimilars is too slow, according to a pharmacy benefit manager (PBM).