June 9, 2017
EU regulators who want to encourage understanding and acceptance of biosimilar medicines might consider improving the drugs’ labels.
May 1, 2017
What can the federal government do to raise clinical trials awareness? Maybe a lot, suggests one organization.
April 10, 2017
Physicians and patients are no longer asking if a biological medicine is the best choice, but – more likely – which biological medicine is the best choice. This opening thought from Alliance for Patient Access Chairman David Charles, MD, set the tone for the organization’s second annual National Policy and Advocacy Summit on Biologics and Biosimilars, held Thursday in Washington, DC.
April 4, 2017
First came biologics, then biosimilars. And soon, explains a newly released video from The Alliance for Patient Access, patients can expect interchangeable biosimilars.
January 24, 2017
New guidance from the Food and Drug Administration directs companies on how to demonstrate a biosimilar’s interchangeability with its reference product.
January 16, 2017
The names of biologic and biosimilar medicines will include randomly generated four-letter suffixes, the Food and Drug Administration announced Thursday.
December 16, 2016
Hepatitis C patients keep waiting…and waiting…and waiting.
December 12, 2016
f policymakers get it right, biosimilars could offer more safe and effective treatment options for patients in the coming years – potentially at lower costs.
November 29, 2016
Despite being cautioned last year by the Centers for Medicare and Medicaid Services, many states still block patients with hepatitis C from receiving curative treatment.
November 16, 2016
The Food and Drug Administration may not have reached consensus on the suffixes that distinguish biological and biosimilar medications, but physicians are of one mind: Meaningful suffixes matter.
