Keep Data in Biosimilar Labeling Clear


Science and medicine have dramatically changed how we manage and treat complex diseases that ravage our families and burden our economy. The nation’s medicine cabinet was once only filled with small molecule drugs derived from a chemical process—the pills patients pick up at their local pharmacies. The treatments of the present and future, however, are heavily reliant on biological therapies that are produced from living organisms and are often administered in doctor’s offices as an injection or through an IV.

Congress understood the importance of biologics in our health care system and how they are transforming treatments for complex diseases such as cancer, rheumatoid arthritis and other debilitating conditions. A few years ago Congress created a regulatory and legal pathway for biosimilars to enter into the U.S. marketplace once the patents of reference biological medicines expire. Biosimilars are biological products that are approved by the FDA because they are highly similar to an already FDA-approved biological (reference) product.

I am a proud member of the Sandoz team, the first manufacturer in the US to receive FDA-approval (Food & Drug Administration) for a biosimilar, Zarxio (filgrastim-sndz).  Biosimilars represent a significant opportunity to expand patient access and potentially lower the cost of vital biological therapies to some of the sickest patients in the US. The RAND Corporation found that biosimilar medicines are projected to save over $40 billion by 2024.

The promise of biosimilars is deeply dependent on a regulatory environment that creates a level playing field for this new class of medicines. One key policy issue being currently debated is what should be included in a biosimilar label. Drug and biological product labels guide healthcare providers in safely and effectively prescribing medications, and as such, are critically important.

The FDA has recently issued guidance which indicates that a biosimilar product label include essentially the same content as its reference product. This format meets the purpose of a product label and provides the requisite information that allows a physician to properly prescribe the product.

Despite the FDA’s recommendation, some stakeholders are suggesting that additional data (including analytical and clinical data) also be included in the label. This information would not provide any necessary information to health care providers about properly prescribing the product to their patients. For example, biosimilar clinical studies are designed to confirm biosimilarity and are not conducted to re-establish safety and efficacy.

As a result, their design is quite different from traditional efficacy and safety studies that support approval of a reference biologic. Therefore, these data could create unnecessary confusion that may limit healthcare provider’s willingness to prescribe biosimilars for their patients.  Moreover, full detail of a biosimilar’s data package is readily available on the FDA website.  This misguided push for the inclusion of additional data would undermine consumer confidence and create unnecessary barriers to utilization of a product that the FDA has determined to be highly similar to and without clinically meaningful differences from the reference product.

I commend the FDA for their efforts to ensure physicians have the information needed to confidently prescribe biosimilars; allowing patients to benefit from greater access to these important therapies. For the first time in the US, the FDA has approved two biosimilar drug products and there are more than 50 currently in development. Biosimilars offer a timely and critical opportunity for American patients, payers, and providers and as such, we need to ensure that the labeling of these products is straightforward and helpful, while still fostering competition.

Carlos Sattler, MD, is vice president of clinical development and medical affairs at Sandoz.

Morning Consult