MedImmune Weighs in on Federal Legislation for Biologic Treatments

Strategic Insights -

Maryland's biotech industry may be impacted by proposed legislation aimed at making biologic treatments, such as antibodies and vaccines, more affordable to consumers. MedImmune Inc., a biotech company with a Frederick manufacturing center, is speaking out about the potential effects of the legislation on their business. The company's executives have met with congressional leaders to discuss the bill, which would establish a process for approving generic versions of biologics, known as biosimilars or follow-on biologics.

Key Takeaways:

  • The proposed legislation would allow other companies to sell generic versions of MedImmune's products, such as its flagship Synagis antibody.
  • MedImmune is concerned about patient safety, intellectual property, and market exclusivity, with the company seeking 12 to 14 years of exclusivity and patent protections.
  • The company wants the Food and Drug Administration (FDA) to determine if it is safe and effective to switch between the original product and the generic version.
  • MedImmune produces multiple biologics, including Synagis and a vaccine, with dozens more in the early research or clinical development phases.
  • The company's vice president for intellectual property, Jonathan Klein-Evans, emphasizes the complexity and cost of developing biologics, making it essential to allow manufacturers to recoup their investments.

Statistics:

  • MedImmune has 12-14 years of market exclusivity in the proposed legislation.
  • The company is seeking 12-14 years of patent protections.
  • The cost of developing a biologic is high, with MedImmune investing in multiple products with dozens more in development.
  • The FDA is contemplating a process for approving biosimilars or follow-on biologics.

Sources:

  • The Frederick News-Post, Md., "Biotech Fears Bill's Impacts Startling" by Meg Tully (no date)
  • Statement of Maryland Sen. Barbara Mikulski (no date)
  • The bill sponsored by Reps. Anna Eshoo, D-Calif., Jay Inslee, D-Wash., and Joe Barton, R-Texas (no date)
  • Letter from Gov. Martin O'Malley to House Majority Leader Steny Hoyer, D-Md., December 2008