'Uncomfortable' Panel Backs Amgen Biosimilar, But Uphill Battle To Sway Docs, Public

Even though the FDA's 26-member Arthritis Advisory Committee on July 12 voted unanimously to back licensure of Amgen Inc.'s biosimilar version of AbbVie Inc.'s Humira (adalimumab), getting there was a chore – potentially signaling the difficulty of what's ahead for companies in educating prescribers and the public, which will be needed to achieve market success.

Indeed, it was apparent early on that several of the panelists had trouble even grasping the idea of what it means to be a biosimilar, versus an interchangeable product.

"You have people who are clinicians and you are asking us to make a judgment that is out of our comfort zone," declared panelist Therese Wolpaw, vice dean for educational affairs at The Pennsylvania State University College of Medicine.

Nikolay Nikolov, clinical team leader in the FDA's Division of Pulmonary, Allergy, and Rheumatology Products, said the agency made every effort to compile an advisory committee that would have the right expertise.

"I can confess that this was extremely difficult, but we did what we could," Nikolov said.

He acknowledged that even though the panel was "somewhat a very diverse committee," many of the clinicians were not familiar with the concepts that were discussed – admitting it was "a lot to ask" of the advisers. (Also see "Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway" - Pink Sheet, 12 Jul, 2016.)

But with the difficulty the committee had in coming to "grips with understanding the purpose and the pathway for biosimilarity," panelist Mara Becker, an associate professor of pediatrics at the University of Missouri-Kansas City, questioned how information about biosimilars will be disseminated to prescribers and patients "so they understand it, too?"

"I think it's going to be really important as we move forward as we address these new agents, not only for acceptability and for safety, but for the public to understand the rationale and how they were approved," Becker said.

"We certainly acknowledge the community's nervousness and need for additional reassurance or confidence that these products would work in different indications," Nikolov said.

Many on the committee said they were concerned about the anxiety expressed by most of the nearly 20 public speakers at the July 12 meeting over whether biosimilars will be similar enough to the innovator biologics, particularly in the non-studied indications, for which the FDA has allowed the data to be extrapolated.

Numerous speakers said they were worried about "non-medical switching," in which they said insurers and pharmacy benefit managers could force patients stable on certain biologics to use biosimilars or interchangeables – insisting they could be subjected to adverse immune responses.

Steven Kozlowski, director of the FDA's Office of Biotechnology Products, pointed out the "reality is" that each lot of an innovator biologic slightly differs from one to another, so "without knowing it, there have been subtle differences" in the drugs patients already have been getting.

Nonetheless, he acknowledged there "really is an education issue" with biosimilars.

While panelist Steve Solga, a gastroenterologist in Bethlehem, PA, said his vote on Amgen's biosimilar was "easy" because the advisers were asked a narrow question, "I've not seen such a disconnect between the charge to the committee and the concerns of the public."

"The disconnect is really quite remarkable," Solga declared.

He insisted there needed to be some sort of a public forum where prescribers' and patients' concerns could be "fully and completely" aired.

Solga also urged the public speakers to try to sit down with Sen. Lamar Alexander (R-TN), chairman of the Senate Health, Education, Labor and Pensions Committee, to try to get congressional action to alleviate some of their concerns, "because we didn't get done what we needed to get done today for them."

"I know we are not being charged to talk about things like cost and other areas, but that's the silo mentality, which a patient never exists in, since they are constantly having to deal with all of these different things," said the committee's consumer representative, Jennifer Horonjeff, a research fellow and patient advocate at the Center for Immune Disease with Onset in Childhood at Columbia University. "We need a way to figure out a way to bridge that gap so that they can better understand."

"We really need to think about the consumer," Horonjeff said, pointing out that biosimilar makers won't succeed until they get patients on board.

What's Industry Doing?

Amgen officials have long acknowledged that for the US biosimilars market to be successful, there needs to be trust in the products by prescribers and patients, meaning companies will need to be transparent and accountable. (Also see "US Capitol Capsule: Biosimilars Uptake Will Fail Without Trust, Accountability" - Scrip, 30 Nov, 2015.)

Amgen said it has created a website to help educate doctors and consumers about biosimilars.

It also is a member of various organizations whose mission it is to provide education about the products, including the Biosimilars Forum, which consists of a mixed bag of traditionally brand-name and generic firms. Other members include Allergan PLC, Boehringer Ingelheim GMBH, Coherus BioSciences Inc., EMD Serono Inc., Epirus Biopharmaceuticals Inc., Merck & Co. Inc., Pfizer Inc., Samsung Bioepis Co. Ltd., Sandoz Inc. and Teva Pharmaceutical Industries Ltd.

Washington lawyer Michael Werner, a partner at Holland & Knight and the policy adviser for the Biosimilars Forum, said the organization has created the Partnership for Biosimilars Education and Access, which is focused on improving the understanding of biosimilars in the US and addressing barriers to access and awareness of biosimilars.

Werner said a key strategy his group takes in trying to ensure biosimilars will be a success in the marketplace is taking its educational efforts directly to prescribers at medical conferences.

"We are using a number of methods to speak to prescribers directly to find out about what they know about biosimilars and to educate them about what biosimilars are, the FDA review process and their clinical benefits and their value to the health system," Werner told Scrip.

He admitted it's likely going to take time before the products are fully embraced, "but we are confident that the more people learn about biosimilars the more comfortable they will be in using them and the more accepted they will be."