FDA Gets Ready for Changes to Biologics Regulation

Drug companies will have more clarity over how the FDA regulates their products following an agency rule revising the definition of certain complex and expensive drugs.

The Food and Drug Administration, in a rule set to publish Friday in the Federal Register, squares its regulatory definition for those drugs, called biologics, with the definition Congress agreed to in a spending deal in December 2019.

The rule is aimed at setting the framework for a new requirement, set to take effect March 23, under which companies seeking to bring certain drug products to market will have to submit an application for a biologic instead of for a simpler drug. The rule also will take effect March 23.

The upcoming change reflects the agency’s effort to remove regulatory hurdles to creating cheaper versions of insulin and other drugs. Insulin is one of about 90 products that will shift to the biologics system in March.

The rule revises the definition of “biological product” to include all proteins, and interprets the term “protein” as “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.”

The FDA said in its rule that codifying that interpretation “will reduce regulatory uncertainty over whether certain products are regulated as drugs or biological products.”

Regulatory Hurdles

Former FDA Commissioner Scott Gottlieb has previously said the upcoming requirements will make it easier for companies to create cheaper versions of insulin and lower costs for patients.

Biologics are made from living cells and are harder to copy than traditional small-molecule products that fall under the FDA’s “drug” category.

Generic approval for small molecule drugs requires companies to prove that their product is the same as the brand version. But that has been virtually impossible for complicated drugs like insulin because of their molecular makeup.

Companies seeking to bring cheaper versions of biologics to the market only have to prove their products are “highly similar” to the original branded version of the drug.

March Transition

Any new protein product approved after March 23 will get 12 years of exclusivity, compared with the three to five years they would have gotten before. More drugs will eventually be eligible for a longer exclusivity period under the change, but those drugs also will likely face more competition than they would have beforehand because of their chemical makeup.

Products that are already set to shift to a biologics application on March 23 aren’t eligible for the 12 years of biologic exclusivity.