Few people question the notion that biosimilar drugs will someday lower the cost of biologic medicines and improve patient access to advanced treatments. However, the transition isn’t exactly on a fast track.

In the eight years since the Food and Drug Administration (FDA) opened an approval pathway for biosimilars, only 11 such drugs have cleared regulatory review in the U.S., and just three are currently being prescribed to patients. “The market for these products is not advancing as quickly as I hoped,” FDA Commissioner Scott Gottlieb said in a statement on June 21.”[i]

In the same statement, the FDA announced plans to withdraw existing guidance on how to assess similarity between biosimilars and reference products. The Agency said in the future, it will issue revised guidance that will reflect advances in analytical techniques, taking stock of challenges trial sponsors face when trying to account for potential lot-to-lot variability.[ii] Noting that these follow-on treatments can cost hundreds of millions of dollars to develop, Gottlieb said, “It’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain.”

In fact, figuring out how to maximize the benefits and cost savings  of biosimilars is no simple task—as speakers explained and discussed in multiple panel discussions last week at the Drug Information Association (DIA) annual meeting in Boston. From an industry perspective, hurdles to overcome include, complexity of development, lack of familiarity with biosimilars among physicians and nurses, ongoing debates about interchangeability, regulatory confusion, and the persistent drain on resources caused by patent litigation.

DIA Insights

During DIA panel discussions we chaired or participated in, a number of speakers highlighted risks for biosimilar developers in an environment where production processes and methods are not publicly disclosed. Developing drugs without that critical information reduces the odds that the follow-on product will be “highly similar” to the reference product.

In elucidating other obstacles on the path, panelists also commented on the reluctance of investigators to participate in biosimilar trials, with some expressing the view that “there’s already a drug available for my patients.” In other words, unless there’s a significant price differential—well beyond the 15 percent we’re currently seeing, on average[iii]—some physicians feel biosimilars are fixing a situation that isn’t broken.

Despite these and other hurdles to biosimilar adoption, many people in our industry believe the new drugs will eventually find their footing. When that happens, there will be disruptions in the biopharma marketplace, which may present opportunities for trial sponsors who are deploying cutting-edge techniques and practices. We know, for example, that many physicians are uncomfortable prescribing biosimilars for indications that weren’t part of the protocol.  Perhaps this is an opportunity for sponsors to leverage Real World Evidence to strengthen their case—both to physicians and payers.

Certainly, comparisons with originator products will become easier and more compelling over time. Consider recent developments in Europe, where adoption rates in multiple disease categories are much higher than in the U.S.[iv]  Panels predicted that we will soon see European data on patients who have been switched from an originator product to a biosimilar, and then switched back as the price on the branded product falls.  Such information, published in respected journals, could be useful both to trial sponsors in the U.S. and to Medical Science Liasons (MSLs) engaging with medical teams.  

Naming Conventions

The recent attempt by U.S. regulators to clarify issues involving analytical similarity of biosimilars comes on the heels of the FDA’s guidance on nonproprietary naming of these drugs, which also clarifies the utility of the products. That guidance requires developers of biologics and biosimilars to attach randomized four-letter suffixes to all nonproprietary drug names.

The objective behind the new naming convention is to improve pharmacovigilance and post-marketing safety, making it easier for manufacturers, researchers, regulators and other stakeholders to track each drug throughout the product life cycle—in adverse event reports, patient records, billing statements, and all other settings. This will also help avoid substitution of a biosmilar product that hasn’t been certified as “interchangeable.”[v]  

What’s Next?

While the FDA prepares updated guidance, common sense is the best course of action for biosimilar developers to follow as they navigate many of the obstacles discussed in sessions at DIA. For instance, it makes no sense to embark on biosimilar development without a thorough assessment of the competitive landscape, market potential and intellectual property issues. In the same way, best practices in biologic drug development should be applied to biosimilars—whether it’s the need for early and frequent dialogue with regulators or engagement with the Centers for Medicare & Medicaid Services, as well as with private payers.

It’s important to remember that biosimilars are still new in most clinical settings. And, while “similar,” they are rarely if ever identical to the reference product, owing to production processes that differ at a cellular level. For these and other reasons, a portion of physicians and patients will continue to harbor concerns–especially if biosimilars come to be substituted for originator drugs without the knowledge of prescribing physicians in some circumstances.

All of this means communications in physician- and patient-centric contexts will grow in importance as more biosimilars come on the market. Education campaigns focused on doctors and nurses will be indispensable to assure that accurate information is transmitted to patients. Doctors—as much as regulators and payers—will be looking for data that present the most complete picture. Biosimilar developers must be prepared to deliver nothing less.

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