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Biosimilars need better labeling: PhysiciansIn FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing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.
New forum expands access to biosimilarsThe non-profit Biosimilars Forum was launched in May 2015 to offer credible, sustained, and unbiased education about biosimilars. The founding members of the Biosimilars Forum represent the majority of companies with the most significant US biosimilars development portfolios.
New forum created to expand access to biosimilarsA coalition of pharmaceutical companies has formed the Biosimilars Forum, a nonprofit seeking to expand patient access to biosimilars in the United States.
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.