Robert G. Bell, Ph.D. is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.
I have been involved with biologics development and production for many years and have participated in numerous global scientific and regulatory discussions over the last 17 years regarding the development of biosimilars. Europe, as well many countries throughout the world, has set a model that the United States should emulate regarding the development and registration of biosimilars. Europe has produced over 20 biosimilar- and product-specific guidelines and approved multiple biosimilar products that include epoetin alfa and zeta, filgrastim, somatropin, and the Committee for Medicinal Products for Human Use has recommended approval for the first monoclonal antibody (infliximab). India has over 30 biosimilars that include EMA approvals for vaccines, insulins, PEG-filgrastim, and rituximab. In contrast, the United States has no approved biosimilars under the 351(k) submission process and only several biosimilar guidelines in draft form.
With many more Americans providing their own health insurance, the cost of life-saving affordable biosimilar biologics becomes an immediate need in the U.S. health care system. Mutual recognition by the FDA of the approved EMA biosimilar registrations would facilitate making these therapies available to millions of Americans. The EMA-approved biosimilars have undergone the appropriate comparability testing that demonstrates that these products are safe and efficacious and have been administered to millions of patients. In addition, it will reduce unnecessary animal and human testing and lessen the environmental impact. User fees would still be collected by the FDA and the appropriate regulatory reviews and preapproval inspections conducted. Instead of being years behind, we could jump start the U.S. health care’s biosimilars initiative by mutually recognizing the EMA approved biosimilars and allowing the previously generated data in the EMA biosimilars registrations to be the basis for a U.S. biosimilars approval.