Lowering Drug Costs and Prices by Expanding Access to Biosimilars

Jeffrey A. SingerToday Senator Mike Lee (R ‑UT) introduced theBiosimilar Red Tape Elimination Act. Thebill seeks to reduce health care costs by streamlining the Food and Drug Administration ’s process to approve biosimilar drug products. It does this by prohibiting the FDA from requiring biosimilar drugs to undergo “switching studies” before the agency approves them as interchangeable with the original biological medicine.Unlike conventional medicines, which drug companies chemically synthesize to a specific molecular structure, biological medicines have natural sources, are complex, and may contain combinations of carbohydrates, proteins, nucleic acids, and even living material such as cells or organisms. Vaccines and blood products are examples of biologicals. When conventional drug patents expire, pharmaceutical makers produce generic versions to compete with the original drugs. The competition usually causes prices to come down. When biological drug patents expire, drug makers make biosimilar versions to compete with the original, thus driving down prices.Biological drugs were only 0.4 percent of U.S. prescriptions, yet they accounted for46 percent of U.S. drug spending in 2018. FDA regulations can make itcost up to $250 million and take up to eight years for a drug maker to bring a biosimilar to market. The barriers to entry for biosimilars are much more challenging to overcome than those typically seen for generics.One of the barriers is the FDA ...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs