WASHINGTON, D.C. — The U.S. Food and Drug Administration announced new draft guidance aimed at reducing the cost and complexity of developing biosimilar medicines, a move the agency says could help expand access to lower-cost alternatives to expensive biologic drugs.
What This Means for You
- Drug developers may face fewer testing requirements when creating biosimilar medicines.
- The changes could reduce certain study costs by up to 50%, potentially lowering drug prices.
- Biosimilars provide lower-cost alternatives to biologic treatments used for diseases such as cancer and autoimmune disorders.
The guidance, released March 9, recommends eliminating certain clinical pharmacokinetic studies — tests that measure how a drug moves through the body — when scientific evidence shows they are unnecessary.
New Guidance Streamlines Testing Requirements
Pharmacokinetic studies, commonly called PK studies, evaluate how drugs are absorbed, distributed, and processed in the body.
Under the draft guidance, the FDA said some biosimilar developers may be able to rely on alternative analytical testing methods rather than conducting certain clinical PK studies.
The agency estimates the change could reduce PK study costs by as much as 50 percent, or roughly $20 million per study.
“Streamlining biosimilar development reflects our ongoing commitment to lowering drug costs for everyday Americans,” said FDA Commissioner Dr. Marty Makary. “Using common sense, we are embracing more precise analytical testing approaches than have been used in the past.”
Lower-Cost Alternatives to Biologic Drugs
Biologic drugs are complex treatments often used to treat conditions such as cancer and autoimmune diseases.
Although they account for about 5 percent of prescriptions in the United States, biologics represent roughly 51 percent of total drug spending.
Many biologic medications cost hundreds of thousands of dollars per year.
Biosimilars are products designed to work the same way as existing biologic drugs, much like generic drugs serve as alternatives to traditional brand-name medications.
The FDA said expanding biosimilar development could increase competition and reduce treatment costs.
Building on Earlier Regulatory Changes
The latest draft guidance follows an earlier policy announced in October that reduced certain comparative efficacy studies required for biosimilar approval.
Those studies, which compare how well different treatments work, can take one to three years to complete and cost approximately $24 million.
The FDA said the updated recommendations reflect the agency’s growing experience reviewing biosimilar applications since the approval pathway was created.
Revised Scientific Guidance
The new document updates guidance related to the Biologics Price Competition and Innovation Act, a 2009 law that created a faster approval pathway for biosimilars.
Specifically, the revised guidance allows developers, in some cases, to rely on clinical data from comparator products approved outside the United States rather than conducting additional studies comparing the biosimilar with a U.S.-approved reference drug.
The agency also withdrew earlier guidance issued in 2015 on demonstrating biosimilarity, saying its scientific approach has evolved significantly since that time.
Growth in Biosimilar Approvals
Since the biosimilar approval pathway was established, the FDA has approved 82 biosimilar products.
These medications provide alternative treatment options for conditions including cancer, rheumatoid arthritis, diabetes, Crohn’s disease, and osteoporosis.