By Ken Congdon
Biosimilar drugs have been available in other countries for nearly a decade. In fact, more than 19 biosimilars are currently approved for use throughout Europe. However, the FDA only recently approved its first biosimilar for the U.S. market — Novartis’ Zarxio, a biosimilar version of Amgen’s Neupogen — on March 6 of this year. This event marks the beginning of a new era in U.S. medicine that will undoubtedly reshape the country’s pharmaceutical landscape.
While only one biosimilar is currently approved for use in the U.S., several others are under development. These emerging therapies have the potential to save patients and the healthcare industry billions of dollars over the next decade because of the reduced R&D expenses necessary to produce these drugs. The rise of biosimilars is welcome news to pharmaceutical manufacturers like Novartis and Pfizer, who have made substantial investments in biosimilar development. At the same time, it’s potentially troubling for manufacturers like AbbVie and Amgen, who currently produce blockbuster biologic drugs set to lose their patents over the next few years.
However, many unknowns still surround biosimilars in the U.S. The market is in its infancy and malleable. With this in mind, pharmaceutical manufacturers on both sides of the biosimilar equation have a profound opportunity to shape the perceptions surrounding these medicines, and ultimately, their use.
Key Differences Between Biosimilars & Generics Will Impact Adoption
Biosimilars are often referred to as the “generics” of biologic drugs. However, there are several key differences between biosimilars and generics — differences that go far beyond molecular makeup. For instance, the FDA has not yet issued guidance for biosimilar product labeling. While the FDA mandates that generic drug labels and inserts be identical to branded versions, no such requirement has yet been levied on biosimilars. A key reason for this is a biosimilar (as the name suggests) isn’t identical to a biologic drug, just similar. Only the primary amino acid sequence of the protein in a biosimilar must be identical to the biologic, other features of the chemical structure may be made by the biosimilar manufacturer that could affect labeling.
The fact that biosimilars aren’t considered equivalent to biologic drugs the same way generics are to branded small molecule medicines creates another key differentiator. Many state laws permit or even mandate pharmacists to automatically substitute a branded version of a medication with the generic version. The two products are viewed as interchangeable. Thus far, the FDA has not granted the same interchangeable status to any biosimilars. As a result, physicians will have to specifically name the biosimilar in the prescription in order for the drug to be sold and administered.
Physician Confidence Can Make Or Break Biosimilars
Physicians have always been crucial to determining the ultimate success or failure of prescription drugs. After all, patients need their physician’s permission in order to receive these therapies. That’s one of the main reasons the pharmaceutical industry spends so much money marketing to healthcare providers. The fact that physicians need to refer to a biosimilar by name for the drug to be dispensed makes doctors even more influential in the widespread biosimilar adoption and use. Physician awareness, perceptions, and opinions of these medications will dictate the fate of biosimilars, and according to a recent report by Quantia titled Reading The Signs: A Roadmap For Engaging Physicians In The Biosimilars Discussion, there’s a huge opportunity for pharmaceutical manufacturers to influence physician behaviors surrounding these drugs.
According to the survey of nearly 300 PCPs and specialists, 94 percent of respondents believe biosimilars will provide value to healthcare, but only 57 percent indicate they would be “very likely” (17 percent) or “somewhat likely” (40 percent) to prescribe potential biosimilars for the biologics they currently prescribe. Furthermore, while 41 percent of prescribing specialists surveyed said they were early adopters of generic small molecule medications, only 21 percent of these same respondents said they would be “very likely” to prescribe a biosimilar.
The reason for this discrepancy is directly linked to the mystery and uncertainty surrounding biosimilars from a physician perspective. For example, only 53 percent of respondents to the Quantia survey were even aware that the first biosimilar was approved by the FDA, only 38 percent were aware of a biosimilar under consideration for approval that would be relevant to their patient population, and only 33 percent could name a biosimilar under consideration for FDA approval.
Furthermore, it appears that prescribing specialists that are aware and knowledgeable about biosimilars have strong concerns about the safety and efficacy of these medications. Only 12 percent of these respondents were “very confident” that biosimilars are as safe as the original, and 22 percent are “not at all confident” that biosimilars are as effective as the original biologic. In addition to safety and efficacy concerns, prescribing specialists also had questions regarding the regulations related to biosimilar/biologic drug substitution and best practices for evaluating when to prescribe a biosimilar versus a branded therapy.
Best Practices For Educating Physicians On Biosimilars
It’s clear that physicians recognize the potential value of biosimilars, but they don’t feel they have enough specific information to prescribe these emerging therapies with confidence. This provides pharmaceutical manufacturers with a huge opportunity to shape physician perceptions in this area. For example, manufacturers preparing to launch new biosimilars should strive to educate doctors as to how their therapies are on par with (or better than) their biologic counterparts from a safety and efficacy perspective. Conversely, manufacturers of branded biologics should inform physicians about the specific attributes of their biologic compound and the potential dangers of switching to a biosimilar.
The Quantia report provides several recommendations for how pharmaceutical manufacturers should engage physicians in this educational effort: