AGA Survey May Indicate Pharma's Acceptance Of Biosimilars

By Trisha Gladd, Editor, Life Science Connect

In a recent article, I spoke with CEO Bert Liang from Pfenex, a biosimilars developer and producer, about the unresolved regulatory issues around biosimilars. Some of these included extrapolation (using a biosimilar to treat an indication for which only the reference product was approved) as well as interchangeability between biosimilars and the original drug at the physician and pharmacist level. However, a recent survey by the American Gastroenterologist Association (AGA) reveals that while biosimilar manufacturers are still battling challenges in order to bring these drugs to market, at least some members of the medical community will welcome them with open arms once they’re available.

Low Prices Appealing But Concerns Remain

When it comes to prescribing bipharmaceuticals, 96 percent of respondents said they currently prescribe biologic drug therapies to patients. With such a large number prescribing them, it should come as no surprise that many of the gastroenterologists surveyed also deal with the problems that come with expensive biologics. Per the survey, “Almost 60 percent of all respondents said they have had a patient’s biologic treatment switched due to insurance company rules. Eight-seven percent of respondents are concerned about pre-authorization for biologics, including 61 percent who are ‘extremely’ or ‘very’ concerned. Delay in treatment (39 percent) was the top concern about the need for pre-authorization approvals.”

Even with only 40 percent of respondents showing high or extreme familiarity with biosimilars (51 percent were only somewhat or slightly familiar), the concept of an equally effective biologic at a lower price is very appealing. This was represented by the 72 percent of respondents who reported “that they would be likely to prescribe biosimilars if they became available in the U.S., with 49 percent ‘extremely’ or ‘very’ likely to prescribe.”  The majority of respondents of the survey were also in favor of interchangeability and extrapolation.

However, information I gleaned from the press release revealed the issues industry still needs to overcome to make biosimilars a drug the medical community can trust:

• 80 percent of respondents say they are very concerned with the level of clinical similarity in terms of effectiveness and safety to the reference biologic and the biosimilar efficacy
• 78 percent of respondents are very concerned about biosimilar safety/immunogenicity
• Among respondents who are unlikely to prescribe biosimilars, 69 percent report that they would be unlikely to prescribe biosimilars because they do not have experience with biosimilars
• 66 percent of respondents who are unlikely to prescribe biosimilars believe there will not be enough clinical data on biosimilars
• 65 percent of respondents who are unlikely to prescribe biosimilars say they need time to evaluate the effectiveness of biosimilars
• 55 percent of respondents believe that pharmacy-level substitution of interchangeable biosimilars should only be allowed with prescriber notification
• 35 percent of respondents believe that pharmacy-level substitution should never be allowed

Clearly, gastroenterologists share only a fraction of the areas where biosimilars could be used, but the results of the survey could still serve as a good indication of where the rest of the U.S. pharmaceutical industry stands on the acceptance and use of this “new” type of drug. Based on just this survey, it seems that while challenges exist, working to overcome them may be a worthy effort.