Breaking Through on Biosimilars: Delivering innovation and more affordable medicines for America's patients
Breaking through on biosimilars report cover

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For Partners & Members

Biosimilars are critical to ensuring patients have access to medicines they need. Offering lower costs and effective treatments, biosimilars are an essential innovation for America’s patients. If allowed to mature, the U.S. biosimilars market could save patients billions of dollars.

But biosimilar manufacturers face challenges getting into the market. These challenges are related to the regulatory uncertainty that corresponds with the development of the approval pathway as well as anti-competitive market access tactics employed by reference product manufacturers. As biosimilars try to wrestle market share from their reference products, they also encounter artificial hurdles intended to thwart competition and keep them from staying in the market once they have managed to develop a product. This hurts American patients.

The Biosimilars Council has released a white paper recommends policies to encourage U.S. biosimilars growth and competition.

“Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines to America’s Patients,” provides solutions to current challenges in biosimilars market development including:

  • Hurdles intended to thwart competition, such as restrictive access to reference products, patent abuses and trade agreements;
  • Obstacles to market-based competition once the FDA has approved an application, including naming, labeling, interchangeability and reimbursement; and
  • Efforts to disseminate misinformation to patients and health care professionals to slow biosimilar uptake.

Read the executive summary and download “Breaking Through on Biosimilars: Delivering More-Affordable, Innovative Medicines to America’s Patients.”

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