Testifying before Congress in April, FDA Commissioner Margaret A. Hamburg, M.D., sought to reassure lawmakers: “We are developing a science-based process for bringing safe and effective biosimilar and interchangeable products to market, which should increase competition and create substantial savings for patients, healthcare providers, and insurers.”
More than a year after issuing three draft guidances on biosimilars, however, FDA has been unable to show industry and others little progress beyond a fourth draft guidance issued in March on formal meetings between the agency and biosimilar sponsors. And judging from comments by drug developers during a comment period that ended May 31, industry has numerous questions it wants FDA to address.
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