Biosimilar Leaders Compliment Pfizer For Calling Out Fellow Innovators, But Should FDA Play A Role To Dispel Misinformation?
Executive Summary
Industry speakers at AAM's GRx and Biosims conference discussed whether FDA should play a role, or whether education should fall solely on the shoulders of sponsors.
Biosimilar industry leaders have thanked Pfizer Inc. for calling out fellow innovator companies in a citizen petition for suggesting that biosimilars are not as safe and effective as originator biologics, but the firms have some disagreement about the role of the US FDA in quelling the spread of misinformation.
Pfizer specifically requested that the agency publish guidance detailing the types of communications about reference products and biosimilars that would be false or misleading, such as any suggestion that there is a clinical difference between reference products and biosimilars. (Also see "Pfizer Wants FDA To Stop Sponsor Promos From Implying Biosimilars Are Inferior" - Pink Sheet, 28 Aug, 2018.)
"Kudos to Pfizer," Chip Davis, President and CEO of the Association for Accessible Medicines (AAM), said Sept. 5 at the trade group's GRx and Biosims conference.
"I think it is worth publicly acknowledging some of the recent efforts undertaken by Pfizer, yes Pfizer, for challenging the anti-competitive commercial strategies that have been employed to block off competition," Davis continued. "The company has been very consistent and very public in calling out some of their brand peers for going out of their way to disparage biosimilars as a class in an effort to maintain market share and profit."
Pfizer has also sued Johnson & Johnson saying that its contract with insurers for its TNF inhibitor Remicade (infliximab) essentially block coverage of Pfizer’s biosimilar Inflectra (infliximab-dyyb), which was developed in partnership with Celltrion Inc.
Lupin Ltd. Senior Vice President for Global Licensing and Business Development Gary Deeb also extended praise to Pfizer in a separate panel at the conference Sept. 6, where he slammed innovators for spreading "fake news" about biosimilars. (Also see "Biosimilars: Is Small Dip In Development Indicative Of Sustained Downward Trend?" - Pink Sheet, 11 Sep, 2018.)
Both Deeb and Momenta Pharmaceuticals Inc. General Counsel and Senior Vice President Bruce Leicher called on FDA to set clear guidelines on what constitutes false and misleading information from brand companies about biosimilars.
"The FDA has to approve clear rules on what's considered false and misleading comparative advertising," Leicher said. "And the FDA has a very important role here in challenging the communication about comparative advertising that suggests that somehow biosimilars are different.
"You have a determination that there are no clinically meaningful differences, so it should be a black and white case in my opinion for the FDA to start enforcing those rules," Leicher added.
Other speakers at the conference, and at a Sept. 4 FDA public meeting on ways to increase the availability of biosimilars, also suggested bold statements from FDA about biosimilars could make a huge impact on their acceptance. (Also see "From Interchangeability To Exclusivity: US FDA Looks For Ways To Make Biologics Market More Competitive" - Scrip, 7 Sep, 2018.)
One Speaker Disagrees
There was at least one speaker at the AAM conference who suggested maybe FDA should not step in to dispel public misinformation about biosimilars.
Instead, Mike Woolcock, senior vice president of Apobiologix, suggested that it is the responsibility of industry and groups like AAM "to make sure that we get the right information out there."
"We've had situations in other parts of the world where regulators have had to step in," Woolcock said. "But that's when the brand companies have attacked the regulator directly or the regulator's choices. So if the messaging is, 'The process of approving biosimilars is bad,' then the regulator should defend itself, no doubt."
But if the messaging is suggesting that biosimilars are inferior, Woolcock says, "it is actually incumbent upon us to actually defend our position as an industry, as manufacturers to defend our products."
Other biosimilar sponsors have also said the industry needs to do a better job on education. (See sidebar.)
The behavior by innovators, Woolcock added, "is nothing new."
"We've been around long enough to know that," Woolcock said. We can go back to Hatch-Waxman, go back to that time period, we saw the same sort of things. We're seeing exactly the same thing today that we saw 20 years ago."
Chrys Kokino, head of biologics for North America at Mylan NV, contended at the conference that FDA should be playing a role in quashing misinformation about biosimilars. He did, however, agree that biosimilar sponsors need to be taking a much more active role themselves in educating physicians to help change their attitudes.
This sentiment was echoed by Louis Tharp, co-founder and executive director of the Global Healthy Living Foundation, who speculated that the biosimilar industry is not spending a sufficient amount of resources on education, which he said is particularly dangerous in the digital age.
"We now have the Internet," Tharp said at the conference Sept. 7. "And what we get is a lot of noise. And what we get is everybody having the luxury of their own facts. And that's a very dangerous situation."
Nevertheless, FDA has already launched an education campaign for providers and patients, which includes graphics and other information explaining the basics of biosimilars. (Also see "Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching" - Pink Sheet, 24 Oct, 2017.)