New Regulatory Pathway for More Than 100 Biological Drugs, Including Insulin & Growth Hormone


On March 23r, 2020, FDA announced the formal transition to a new regulatory pathway for certain biosimilar, or interchangeable, versions of biologic drugs, including insulin and growth hormone (GH).

Read the Press Release here

The FDA’s announcement marks the end of a 10-year timeline created through the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that allowed a transition period for stakeholders. Up to now, the transitioned products were classified as small-molecule drugs and were regulated under the Food, Drug, and Cosmetic (FDC) Act. Henceforth, an application for a biological product, previously approved under section 505 of the FDC Act, will be deemed to be a license for the biological product under section 351 of the Public Health Service (PHS) Act. FDA admits in their press release that it has been difficult to develop generic versions of these drugs under the FDC Act mainly due to limitations on the scope of data that could be relied upon during a generic drug application. Therefore, there has been insufficient competition and overall fewer treatment options in higher prices. For example, under the previous pathway, only two biosimilar insulins have been approved in the U.S.: Basaglar® (Eli Lilly), which was approved as a follow-on to Sanofi’s Lantus® (insulin glargine) in 2015, and Admelog (Sanofi), which was approved in 2017 as a follow-on to insulin lispro (Humalog®, Lilly). FDA aspires to reverse this status quo, enhance competition, and therefore, indirectly, reduce healthcare costs, as the cost of biosimilars is estimated to be 15-35% lower than the reference product.

Read more on the Biosimilars Action Plan here

Nearly 100 drugs are affected by the transition. In addition to insulin and GH, biologic drugs used in the treatment, diagnosis, and prevention of respiratory distress syndrome (RDS), fertility-related disorders, Cushing’s syndrome, deep vein thrombosis (DVT), Gaucher’s disease, etc. are moving to the new regulatory pathway and are expected to profit from the abbreviated licensure pathway.

List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020, here

Key points for patients outlined here

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