To See The Biosimilar Future, Look To The Past

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

I have a coworker who often leaves “gifts” on my desk. To date, I have received at least 150 fortune cookies. (Each cookie is generally accompanied by a lonely packet of soy sauce or duck sauce, as well.) One of my favorite fortunes, currently taped to my computer, reads: “Be not afraid of growing slowly, be afraid only of standing still.” Though this fortune was not spoken word for word, it was an undercurrent in many of the presentations given at the GPhA Biosimilars Council Leading On Biosimilars conference.

As GPhA CEO Chip Davis emphasized in his speech, “If we as an industry don’t stand together and tell our story, we run the risk of others defining it for us. We can and should be the authors of our narrative.” Some of the biggest concerns raised during the two-day conference circulated around naming, labeling, and reimbursement procedures for biosimilars. Many fear the current policies laid out will lead to diminished trust among doctors and patients and hinder uptake. In other words, the biosimilar industry is afraid of being stuck standing still.

Safety Concerns: Genuine Or Fearmongering?

Having spent 20 years working on the branded side of the pharmaceutical sector, Davis acknowledges the importance of innovation for a field like pharma. But, as Davis (and many other experts) articulated, innovation alone will not “finish the job” of providing patients, payers, physicians, and the government with all their sought-after outcomes. Given the explosion of drug pricing concerns in recent months, it’s clear innovation must go hand-in-hand with affordability.

“From my perspective, the generic and biosimilar sectors are where innovation and affordability intersect,” Davis argued. But in today’s politically charged atmosphere, Davis sees some great risks arising if biosimilars are not understood by policy makers and the media. He calls attention specifically to the rise of a “say one thing, do another” approach amongst certain people and entities. While these parties may publicly state their support of biosimilars, they side with policies — for instance, the controversial naming and reimbursement policies — that could ultimately undermine the biosimilar market. Davis warns it’s dangerous to overlook these actions, as patients and providers would suffer the consequences.

He drew our attention to the recent CVS decision to cut Neupogen and Lantus from its formulary in favor of the biosimilar Zarxio and follow-on biologic Basaglar, respectively. Following this news, a number of patient organizations (some of which are industry-funded) expressed concern this decision comes between doctors and their patients and puts health and safety at risk. However, these fears overlook several important facts about biosimilars — the most important being that these treatments underwent rigorous scientific reviews from the FDA in order to be released to the market. Davis argues this fact is often left out of biosimilar messaging, and not by accident.

There are, of course, going to be different perspectives and concerns voiced as this industry takes shape. But, these concerns are often exclusive to biosimilars and do not take into account the brands, which also differ from batch to batch and often replace other biologics on formularies. A great example of this occurred in Norway, when Novo Nordisk won the tender back from Sandoz’s human growth hormone (HGH) biosimilar Omnitrope. There were never any concerns voiced about switching patients back from the biosimilar to the brand in this situation.

In the U.S., Davis referenced Express Scripts’ and CVS’ decisions to cover different hepatitis C products on their 2017 formularies. “It’s fair to ask ‘What’s the difference?’” Davis said. “Are we to believe that the formulary decision between two branded products is commercially acceptable and patient-focused, but the decision between a brand and a biosimilar isn’t?”

Will History Repeat Itself With Biosimilars?

Davis charged the industry with combatting fearmongering statements and scientifically unsupported scare tactics. But he also said he is confident these voices will be overcome, seeing how the small molecule generics industry played out. Davis quoted Shakespeare’s The Tempest, “What is past is prologue.” Biosimilars are currently subject to a number of the same questions about safety, effectiveness, and economic potential as generics were back in the early ’80s. When generics entered the market, there were several now familiar arguments: Generics would harm R&D; brand companies would be denied the patent extension they were promised through Hatch-Waxman; any savings realized would be small and were not guaranteed. There were also concerns about how the FDA would investigate safety issues arising from the use of generics. However, none of these pervasive arguments or fears came true. In fact, in all of these instances, the opposite happened, according to Davis.  

The Office of Technology Assessment found brand R&D spending increased three- to six-fold 20 years after Hatch-Waxman. Since September of 1984, the U.S. Patent and Trademark Office has granted roughly 900 of the 1,350 requests for brand patent extensions — a total of 1,000 years of extended patent life. (This would not be the best news in the biologics industry.) Savings from generics over the past 12 years surpassed $2 trillion, and 88 percent of all prescriptions doled out today in the U.S. are generics. Of course, this level of uptake did not happen quickly. Generic uptake was only 30 percent after five years. It hit 50 percent in 2004 and 76 percent in 2010. A figure presented by Ronny Gal reveals U.S. biosimilar uptake of Zarxio, as of July 2016, was around 13 percent, and Zarxio has only been on the market for a year. Given Express Scripts’ and CVS’ decisions to prioritize this treatment on their formularies, 30 percent market uptake of biosimilars will likely be achieved in much shorter time than five years.

“We need to make sure policy makers don’t buy into stale arguments that are more focused on expanding brand dominance at the expense of increasing access to more cost-effective biosimilars,” Davis argued. There is a striking lack of scientific evidence behind claims that biosimilars potentially put patient health and safety at risk. But we are beginning to see studies publishing scientific data demonstrating the safety and efficacy of biosimilars. Davis referenced one article published in the Annals of Internal Medicine, which showed Enbrel, Humira, and Remicade biosimilars have the same efficacy and safety profile as the reference drug. In addition, a European infliximab switching study in ulcerative colitis and Crohn’s disease showed the biosimilar had a 95 percent comparable efficacy rate in new patients and those who made the switch from Remicade.  

As the U.S. faces the impending election, the pressure is on for biosimilar makers to educate a new administration and Congress. “There’s an old saying in Washington that, if you’re not at the table, than you’re likely on the menu,” said Davis. “In other words, if you are not part of the policy conversation, you may well find yourself the subject of it.”