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.
5 reasons to keep biosimilar names the sameThe Healthcare Supply Chain Association (HSCA), the Generic Pharmaceutical Association (GPhA), and other healthcare stakeholders are calling on FDA to institute a clear policy for biologics and biosimilars.
First biosimilar finally approved by FDAThe approval of the first biosimilar heralds a new era in U.S. healthcare. But the rules for biosimilar use are not quite ready for prime time.
Patient groups bothered over diminished safety standards for biosimilarsPatients for Biologics Safety & Access (PBSA) sent a letter to FDA addressing safety concerns about final FDA guidance documents issued for biosimilars.
Biosimilars need better labeling: PhysiciansIn FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing decisions," including clear statements of a product's approval as a biosimilar to a reference product and whether or not it has been determined to be interchangeable.