Identifying and Addressing "Biosimilar Shenanigans"

“Today’s healthcare system is unsustainable. [US] national health spending is expected to grow at 5.5% each year,” said Carol Lynch, president of Sandoz US and head of North America. Lynch set the stage for a session at the Association for Accessible Medicine’s Access! 2019 meeting by diving into the many benefits biosimilars could offer the US marketplace if they saw greater uptake. Lynch presented statistics showing that “If all approved biosimilars had been marketed in a timely manner, Americans could have saved $4.5 billion.”

Unlike the United States' infancy of the biosimilar market, Europe has much more experience to draw upon. According to Lynch, since 2010, Europe has saved €1.4 billion (approximately $1.59 billion). Furthermore, Europe has more than 700 million patient days of experience, and plans to save anywhere from €11.8 billion to €33.4 billion ($13.44 billion to $38.04 billion) by 2020 with more than 50 biosimilar approvals.

The US biosimilars market has experienced numerous barriers to uptake. Lynch grouped these barriers into 3 buckets: clinical, ease of use, and economic. To discuss the various hurdles posed to biosimilars in greater detail was a panel comprising Tahir Amin, cofounder and coexecutive director of Initiative for Medicines, Access, and Knowledge (I-MAK), Ronny Gal, PhD, senior analyst at Sanford C. Bernstein & Co., and moderator Kurt Hurst, director of Hyman, Phelps & McNamara, PC.

Hurst kicked off the discussion by asking the panelists what their perception is of the marketplace today. “There’s 17 licensed biosimilars but only 5 to 7 are available on the market. Why aren’t there more? What tactics are being used by brand name products and others to suppress market penetration?”

Gal offered his own take on the hurdles posed to biosimilar developers looking to enter the market: “It’s a death by a thousand cuts.” He explained that there are 3 separate factors to consider, a product approval, market entry, and market share. Though the drugs are being approved—and more quickly than ever before–they’re still struggling to make it to market.

“From my perspective, we’ve done studies of the top-selling biologics and the amount of secondary patenting going on is astonishing. People always hear about AbbVie and Humira, but this practice is happening across the top 9 [selling] biologics,” said Amin. His recommendation to counteract this over-patenting is, in his own words, to reform the Biosimilar Price Competition and Innovation Act (BPCIA).

“I think the United States needs to tackle the issue of intellectual property because its rapidly abused. When you look at what is being patented and how it’s being protected, that’s something we don’t talk about enough…you can’t blame the player, you have to blame the system. Patent law and the patent office allow this practice to take place,” he said.

The panel then debated another hot-button issue within the space: the interchangeability designation.

“Interchangeability itself is more of a pain...interchangeability allows the innovator [manufacturer] to argue that anything that isn’t deemed interchangeable is not good enough. Even when [one achieves the designation], no insurer will pay for a noninterchangeable biosimilar when there is an interchangeable on the market, because why do that when there’s another one out there that’s better?” said Gal.

In fact, Gal took it one step further. He suggested that the FDA should “collapse the requirements” for interchangeable and biosimilar products to instead create 1 single designation of an interchangeable biosimilar given that the standard is already very high.

While Amin agreed that he believes the FDA still has some distance to go in terms of finalizing or reforming certain things such as the interchangeability guidance or the Purple Book, he also sees the FDA as needing help from law makers.

“The FDA doesn’t have a huge amount of power to try and curb these shenanigans, so I think it will take legislative effort,” said Amin.