According to a survey conducted by the Biosimilars Forum – a nonprofit organization aimed at advancing biosimilars in the US – 91 percent of US physicians would be willing to prescribe a biosimilar over its branded biologic, given the right circumstances. However, the survey also found that doctors were uncertain about the regulations surrounding the approval process of biosimilars, suggesting that they could benefit from more education about the drugs.
The survey was conducted to assess 1,201 doctors’ perception on biosimilars. These doctors were chosen to participate in the survey based on the fact that they routinely prescribed biologic drugs to their patients.
Right now, only four biosimilar drugs have received regulatory approval in the US, with just one of the drugs – Novartis’ Zarxio – currently available on the market. The hope is that these biosimilars will offer a less-expensive treatment option for patients currently taking pricey branded biologics.
While a biosimilar must demonstrate a high level of similarity to its reference product, without showing any differences in safety or efficacy in order to gain marketing approval, only 45 percent of doctors polled agreed that biosimilars would be “safe and appropriate for use in naive and existing patients.” This result suggests that many physicians may be unaware of the stringencies governing US Food and Drug Administration (FDA) approval of biosimilars.
The survey found that most physicians were unclear on how the regulatory approval process differs from that of branded drugs. Biosimilars are primarily assessed based on their level of similarity to the reference product.
Using this evidence of similarity, the FDA can extrapolate how effective it might be at treating the same indications as the biologic. Only 12 percent of physicians who participated in this survey said they were comfortable with the idea of extrapolating data.
One third of the doctors believed that a pharmacist could swap a biologic prescription for a biosimilar, as is the case with generic drugs. While this is theoretically possible, all four of the approved biosimilars have not been granted interchangeable status which would allow pharmacists to exchange one for the other.
At the time of the survey, only Novartis’ Zarxio was FDA-approved, leading the organizers to speculate that physicians may be more knowledgeable about the drug class now that there are other biosimilars entering the market. Amgen, Pfizer, Novartis and Samsung Bioepis are just some of the big-name pharma companies that comprise the Biosimilars Forum.