FDA finalizes definition of biologics, prepping entry of insulin biosimilars
The action saw the US Food and Drug Administration (FDA) publish its ‘final rule’ to amend its definition of a biological product, one month ahead of the official regulatory change to alter regulatory pathways for certain products on March 23.
Under revised specification, the term ‘protein’ will be deemed to be any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.
This process represents the culmination of a 10-year process transitioning insulin, and other products, such as human growth hormone, to biologic designation.
Previously, the change has been hailed as a means to reduce the cost of insulin medicine, and the most recent announcement continued this line of argument.
“Life-sustaining insulin products are biologics, but to date, there has been limited competition in the marketplace, resulting in fewer choices and higher prices for patients,” said FDA Commissioner Stephen Hahn.
He continued, “This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace.”
However, it is not clear yet how many companies will take the opportunity to enter the insulin market with biosimilars. Sandoz previously told BioPharma-Reporter that it is working, alongside a partner, to develop and market a biosimilar. At the time, the company also noted that the project is still at an early stage and it does not have a ‘clear timeline’ for commercialization.
Despite this, industry analysts have predicted that 2020 will represent a significant year for biosimilars in the US, even though such products have generally had a muted impact on the industry thus far.