Biosimilars Need to Overcome Awareness Problem

Survey finds an overwhelming number of seniors are unaware of what biosimilars are.

Beyond the regulatory hurdles hampering their development, biosimilar drugs also have a serious awareness problem, according to a recent survey.

Conducted by grassroots organization RetireSafe, an advocacy group for American senior citizens, the survey finds that more than 90% of seniors surveyed did not even know what biosimilars are. Furthermore, the survey finds seniors are in favor of strong patient safeguards being put in place for the review and approval process of biosimilars.

“When it comes to new biosimilar drugs, people are rightly concerned and want to keep their drugs safe and effective, so that seniors and other Americans aren’t used as guinea pigs for inadequately tested drugs,” said RetireSafe President Thair Phillips in a press release. “Seniors have made their voice clear that patient safety must come first if we are to reap the benefits of new lifesaving medicines.”

The survey polled 1467 seniors on a variety of issues concerning biosimilar development. A total of 93% of seniors polled were unaware that biosimilars cannot be a generic version of biologic drugs.

Survey respondents also indicated that their lives are dependent on the medications they take, therefore independent research must be required by the FDA prior to approving a biosimilar.

“No medication should be substituted without the permission of the patient,” said one of the seniors in the survey. “People should have information so they may make an informed decision regarding their health and medications.”

The findings illustrate an awareness problem that manufacturers are working to overcome in the development of these complex medications. A flood of patent expirations over the next several years has driven pharmaceutical companies to initiate educational campaigns to spread awareness on the unique aspects of biological manufacturing.

In an interview with Specialty Pharmacy Times, Javier Coindreau, MD, vice president of global medical affairs for the Pfizer Biosimilars Business Unit, noted that manufacturers must pursue education programs to properly inform patients and physicians about the potential of biosimilars.

”Scientific education around our compounds is critical,” Dr. Coindreau said. “We do it all the time with every drug we have on the market and with new drugs we launch, and that’s not going to be different with biosimilars. Of course the content is going to be completely different because it is critical that all of our customers and stakeholders in health care practitioners, patients, etc, understand the biosimilar concept first before we start talking about our compounds.”

A recent report by Moody’s Investors Service estimated biosimilars are at least 3 years away from hitting the US market. While estimates for the savings biosimilars could provide vary, a paper published in February, 2014 on the Social Science Research Network indicates that over the next 10 years, American consumers could save more than $250 billion from biosimilar competition for just 11 biologic drugs if they were approved by the FDA.

“One of the things biosimilars provide is competition, and with that the potential for increased access,” Dr. Coindreau said. “One of the most important reasons biosimilars should be available is because the need for these drugs are huge and in most cases, in these therapeutic areas, access is not easy. So by increasing competition, biosimilars increase access for patients requiring these drugs but who currently don’t have access.”