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Biosimilars need better labeling: PhysiciansIn FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing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.
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.