FDA issues final definition of biologics that could increase access to cheaper insulin

On February 20, 2020, FDA published a final rule amending its definition of a “biological product.” The agency states that this action should make it easier to get cheaper biologics, such as insulin, on the market.

Previously, FDA defined “biological product” as a “protein (except any chemically synthesized polypeptide).” The final rule, which will go into effect on March 23, 2020, further defines “protein” as any alpha amino acid polymer with a specific sequence that is greater than 40 amino acids. This wording now clarifies that insulin, which consists of two polypeptide chains that exceed 40 amino acids in length, is a biological product.

“This move by FDA provides more opportunities for competition for insulin biosimilars in the market, which will lead to greater access to this important medication for patients,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA senior vice president of pharmacy practice and government affairs.

FDA commissioner Stephen M. Hahn, MD, said in statement that the 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.” The agency expects that the move will bring down prices for biologics, which “often carry a heavy price tag,” and allow patients to have access to more choices for these drugs.

While the change could make it easier to market generic insulin and other products whose market exclusivity has long expired, it may take longer to get copies of new complex drugs on the market. Makers of biological products have 12 years of exclusive marketing rights compared with 5 years for small molecule drugs. 

FDA published additional resources for stakeholders, including frequently asked questions documents for patients and health care providers about the regulatory changes.

The agency advises prescribers to continue prescribing insulin and other biologics in the same way they did before the transition. It also advises pharmacists to make no changes in the way they dispense and counsel patients on these medications. Patients should know that the products themselves will not change upon the transition, so it is safe to continue using them as normal.