The FDA has announced that it will hold a hearing to discuss affordability of and access to insulin products, including issues concerning the development of biosimilar and interchangeable insulin products. The hearing will cover scientific standards for evaluating biosimilarity and interchangeability of insulin products; other regulatory considerations, such as whether products approved for use with insulin pumps “raise unique scientific considerations”; aspects of the patient experience FDA should consider; and information resources that should be made available to patients, clinicians, pharmacists, and other stakeholders.
In a related statement, FDA Commissioner Scott Gottlieb said:
“Diabetes takes a tremendous toll on Americans, both physically and economically. … While some patients with Type 2 diabetes can control their diabetes through diet, exercise and oral medications, more than seven million diabetics require daily insulin injections to maintain glycemic control and reduce the risk of health complications. But access to this critical drug can be increasingly difficult for these Americans. Insulin list prices regularly increase by double digits annually. These increases have raised serious concerns about the ability for many patients to access the insulin needed to survive.”
In the statement, Dr. Gottlieb also discusses the “abbreviated pathway” for biosimilar approval created by the BPCIA. According to Dr. Gottlieb, the “transition of insulin from the drug to the biologics pathway will open up these products to biosimilar competition.”
The public hearing will be held on May 13, 2019, from 9 a.m. to 5 p.m at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503B), Silver Spring, MD 20993-0002. The registration deadlines are April 29, 2019 for presenters, May 9, 2019 for speakers, and May 9, 2019 for attendees. The FDA will accept electronic or written comments until May 31, 2019.