Biosimilar Sponsors: We Need To Do A Better Job Educating Physicians And Patients
Executive Summary
Mylan's Chrys Kokino says failure of sponsors to educate "really is a huge miss on our part."
Biosimilar sponsors have been calling on the US FDA to take of more active role in the space of stakeholder education, but it is also an area where companies themselves concede they need to be upping their game.
"Education, education, education," Chrys Kokino, head of biologics for North America at Mylan NV, said Sept. 6 when asked what specifically biosimilar sponsors can be doing better to help facilitate uptake of their products in the US.
Kokino made his remarks on a panel at the Association for Accessible Medicine's (AAM's) GRx and Biosims conference, where education was a repeated theme over the three-day meeting. Although many of the discussions focused on the job of FDA, Kokino said the failure of companies to educate physicians "really is a huge miss on our part."
Reflecting on the experience in the European Union from around 15 years ago before biosimilars became a staple, Kokino explained that sponsors would ask physicians whether they would give a biosimilar to a family member or relative if the needed it. The question was frequently met with hesitation, Kokino said, as innovators had successfully planted a seed of doubt in their minds.
We are now experiencing a similar situation in the US, Kokino continued, while guessing that only about half of the stakeholders in the US "really, truly understand biosimilars."
"It is a lack of understanding," Kokino said. "We absolutely have to do a better job of educating."
Kokino further described sponsor-delivered education as "the core nucleus" for making the best business case to pursue a biosimilar development program.
"We can develop all the programs we want, but if on the backside, there's not the education there to utilize these products to make a corporate business case, these are all sunk costs," Kokino said.
Momenta Pharmaceuticals Inc. General Counsel and Senior Vice President Bruce Leicher agreed, stressing that sponsor efforts to educate "would do a lot to change attitudes." Leicher further suggested that biosimilar companies need to do a better job of educating Congress on issues such as patent thickets and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
"If we want to see changes in the law relating to patent thickets, you need to help the policymakers and the legislators understand what a biosimilar is as well. If they still believe that a biosimilar is a little bit different, they may not be so keen on making legislative change," Leicher said.
On the CREATES Act, which would allow generic or biosimilar sponsors to sue innovators if they refuse to provide enough product samples for testing, Leicher said, "We've been attempting to get a law passed that would facilitate access to reference products to do clinical trials ... And the fact that Congress is having difficulty wrapping its head around passing that law is a function, I believe, of a bunch of misinformation about biosimilars." (Also see "REMS Abuse Website: All Sizzle, No Steak?" - Pink Sheet, 5 Sep, 2018.)
Down On DTC Advertising
When asked whether there is a role for biosimilar sponsors to take a more active role in direct-to-consumer (DTC) advertising, both Kokino and Leicher took a more cynical view, feeling instead that the money would be better spend educating physicians.
"At the end of the day we pay for a physician or a patient to deny accepting this medicine because they haven't been properly educated," Kokino said.
Leicher added that, "Ideally, we want to get to a place where companies don't have to be using sales and marketing tactics associated with brand medicine, because it just increases the costs. But there is certainly role for [AAM] to play and for the companies to play in more general education."
Other Educational Efforts
Industry speakers continued to stress the significant role FDA should have in education, as several of them feel the agency can help by providing simple, short and declarative statements about biosimilars to clear up any confusion. (Also see "Biosimilars: Is Small Dip In Development Indicative Of Sustained Downward Trend?" - Pink Sheet, 11 Sep, 2018.)
"Statements coming from the FDA can help build the confidence in the physician and stakeholder community," Kokino said.
The agency has already launched an education campaign for providers and patients. For example, it has published graphics and other information explaining the basics of biosimilars, such as the science behind their development and their approval standards. (Also see "Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching" - Pink Sheet, 24 Oct, 2017.)
Hillel Cohen, executive director of scientific affairs at Sandoz Inc., noted in a separate panel Sept. 5 that successful educational programs in Europe involved doctors or pharmacists sitting down with patients and explaining to them what a biosimilar is, the basis of approval and the quality of the medicine. He said that he would like to see those programs brought to the US, as they could facilitate patient acceptance of biosimilars and help to dispel half-truths about them, which act as barriers to their uptake.