Sandoz touts value of first biosimilar for cancerThe first biosimilar drug approved by FDA in March was officially launched in the United States on September 3 – at a value compared to competing medications.
Biosmilars’ naming proposal could cause “significant” changesPharmacies should be wary of potential drug name changes that could occur if FDA finalizes its new draft guidance on biosimilar naming, which proposes proper names for biosimilars.
Biosimilars and interchangeability: Many questions, few answersInterchangeability means different things to different stakeholders. Here are some things they will need to agree on.
The five forces that shape the biosimilar pipeline
The five forces that shape the biosimilar pipelineThe biosimilars pipeline is flush with new products, and it could be shortening. Here's why.
The market side of biosimilarsR&D and product manufacture are only the beginning. When the time comes to enter the marketplace, biosimilars still face numerous obstacles.
What’s holding up biosimilar development?Canada, the E.U., South Korea, Japan, India, and Australia — all have had clear regulatory pathways in place for years. The United States has been working on a biosimilars pathway for almost a decade. What's different?
5 reasons to be concerned over proposed Medicare rule on biosimilar codingA Medicare reimbursement policy proposing that multiple biosimilars have the same pricing J-code for Medicare reimbursement purposes could ultimately result in fewer treatment options, according to a group representing the industry.
Court ruling clears way for first U.S. biosimilar launchThe U.S. Court of Appeals for the Federal Circuit in Washington has ruled that Novartis AG’s Sandoz may begin selling the first copy of Amgen Inc.’s Neupogen as soon as Sept. 2.
[BLOG]: 5 reasons biosimilars must have distinguishable namesIn this blog response to the July 13 article "5 reasons to keep biosimilar names the same," Louis Tharp, executive director or Global Healthy Living Foundation, lists 5 reasons biosimilars must have distinguishable names.
A new era in specialty pharmacyAs specialty meds pour out of the pipeline, pharmacists knowledgeable in disease states and side effects stand ready to manage administration and patient monitoring.