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guidances on biosimilars, however, FDA has been unable to show industry and others little progress beyond a fourth draft guidance issued in March on formal meetings between the agency and biosimilar sponsors.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.
Those questions are unlikely to be addressed quickly, given that more than a year has passed since FDA came out with its initial biosimilar guidances, designed to address scientific and quality considerations, as well as answer common questions on biosimilar development. Those guidances sparked mostly good marks, but also requests from a dozen biopharmas in letters and a public hearing for greater flexibility in defining proteins, and tighter standards in naming and labeling follow-on biologics.
“FDA is currently reviewing and considering all comments received from the May 11, 2012 public hearing docket and those from the draft guidance dockets as we move forward to finalize the draft guidances and determine plans for developing future policies on biosimilars, including guidance on clinical pharmacology data to support a demonstration of biosimilarity to a reference product,” FDA spokeswoman Lisa Kubaska, Pharm.D., told GEN on June 19.
Dr. Kubaska said FDA’s Center for Drug Evaluation and Research (CDER) continues to meet with sponsors interested in developing biosimilars. As of June 19, CDER received 56 meeting requests for initial gatherings to discuss biosimilar development programs to 12 different reference products, and held 40. CDER has also received 17 INDs for biosimilar development programs, but additional development programs are proceeding under a pre-IND.
“You might expect that building a new approval program of this complexity takes much time and deliberation, and that certainly has been the case,” Dr. Hamburg said, understating matters in a March 15 address to the Massachusetts Biotechnology Council.
FDA will need more time and deliberation, six drug developers and two industry groups concluded in comments on the agency’s “Draft Guidance for Industry on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.”
“Given the complexity of the issues involved in developing, manufacturing, and approving biosimilars, we hope that FDA will continue to seek stakeholder input openly and transparently in order to best protect patients and to ensure implementation is based on sound science,” the Pharmaceutical Research and Manufacturers or America (PhRMA) advised FDA, in a letter written by Kristin Van Goor, Ph.D., RAC, the industry group’s senior director, scientific, and regulatory affairs.