Biosimilar Regulation Process Brings Safe, Effective Treatments to U.S. Patients

Physicians, scientists, government officials and patient advocates agree that biosimilars, a nascent class of biologic drugs, hold great promise for the future of health care in the United States. We need to set the record straight about biosimilars and put misguided claims about their safety and efficacy to rest.

Biosimilars, which are highly similar but often more affordable versions of biologic drugs like Humira or Enbrel, are being developed to help patients manage serious conditions including cancer, rheumatoid arthritis and other chronic diseases. Like other biologic drugs, biosimilars are made from living organisms (compared to chemical synthesis as in the case of most drugs), which means there is no one-size-fits-all approach to measuring their efficacy during the approval process.

To address this, the Food and Drug Administration uses what is known as a “totality-of-the-evidence” approach to assess the safety and efficacy of biosimilar drugs. FDA scientists will assess a wide range of information – anything from molecular structures to human testing data – when analyzing if a biosimilar product will have the same clinical outcomes as its original reference product.

This approach is crucial to understanding how the FDA regulates how biosimilars are made. Given that the FDA requires biosimilars to demonstrate that they are highly similar to their reference products (and their reference products have already undergone a rigorous clinical trial and approval process), regulators can better evaluate biosimilars without going through a duplicative, expensive and time-consuming trial process.

Once clinical examination confirms the safety and efficacy of a biosimilar product, the FDA makes certain that the physical production process of the drug meets the highest manufacturing standards, as well. Biosimilars must be manufactured, processed, packed and held in facilities that are closely examined by the FDA and shown to be “safe, pure and potent.” The FDA will not – and cannot by law – approve a biosimilar unless it meets this standard.

While biosimilar uptake in the United States is only just beginning, U.S. biosimilar regulation guidelines have been developed using experience from other areas of the world where their use is more common, including Australia, South Korea and throughout Europe. U.S. scientists and officials can learn from the more than 700 million patient days that have been recorded across Europe over the past decade, which provide crucial insights that contribute to the precise regulatory process here. Studies continue to confirm the safety and efficacy of biosimilars for patient use worldwide.

The FDA has recognized the tremendous potential of biosimilars to help improve patient access to treatment and care. It is actively working to promote a vibrant biosimilars market in the U.S. and to educate people about the benefits of these drugs. In fact, FDA Commissioner Scott Gottlieb said in March that the agency was working on new policies to help enhance the regulatory process.

The medical community has applied a meticulous approach as multiple stakeholders work together to build the biosimilar development pipeline in the U.S. Patients and physicians should feel confident that biosimilars undergo extensive and rigorous clinical examination before they are approved. The future of care for patients with serious conditions depends on our support for biosimilars as a safe, effective and affordable treatment option.

Juliana M. Reed is president of the Biosimilars Forum.

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