For U.S. Biosimilar Success, Look Beyond Borders

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

In any industry, there are the experts who become known as the foremost voices of the industry. In the biosimilar space, there are two people who I’d argue have provided biosimilar makers with hope, as well as calls to action to make the nascent market a success. One of these experts is Steinar Madsen of the Norwegian Medicines Agency. At the recent GPhA biosimilars conference, Sanford Bernstein Analyst Ronny Gal referred to Madsen as a “biosimilar evangelist.” In fact, Madsen’s tales of the rampant biosimilar uptake in the Scandinavian countries were so persuasive, Gal claims they inspired a room full of European investors to sell off their innovative companies.  

But the biosimilar evangelist in the U.S. is Bert Liang, CEO of Pfenex and chair of the Biosimilars Council. You can be certain Liang will be cited in an article or a press release emphasizing the importance of biosimilars for the pharma industry. Liang was the first speaker to the podium at the inaugural Biosimilars Council’s Leading on Biosimilars Conference. His discussion about how far the U.S. biosimilar industry has progressed — as well as how far it has yet to go — offered biosimilar makers some important goals to strive for in the years ahead.

Why Biosimilars Should Be Considered Innovative

Liang has been in the business of biologics for 25 years. As such, he’s seen his fair share of innovation within the biotech industry. He witnessed the genomics revolution, as well as the industry’s growing technical capability to evaluate the therapeutic potential of peptides and proteins. Over the past two decades, the industry has benefitted from more comprehensive analytics. He detailed the advances made in bioanalytical characterization during Amgen’s development of Neulasta. By the time the company filed the product with the European Medicines Agency (EMA) and the FDA, there had been a 10-million-fold increase in the sensitivity of bioanalytical characterization. It is because of these technological advances that the biosimilar industry is where it is today. “The very basis of the formation of our biosimilar industry is technological innovation,” Liang stated.

When I began covering the biosimilar space, one of the questions I found myself asking (and writing about) was how “innovation” applied to biosimilars. Indeed, an article in which I questioned if biosimilars fit into the innovation paradigm drew several comments. It seems experts — both in the biosimilar and innovator spaces — had plenty to say about why biosimilars were or were not innovative.  Today, I’ve become more acquainted with payers’ emphasis on medicines that go above and beyond the standard of care, both in terms of mechanism of action and economically. Given the analytical sophistication required to demonstrate biosimilarity, as well as the economic benefit they pose globally, I find it difficult to casually refer to biosimilars as the “knockoffs” and “copycats” many claim them to be. Liang summarized the biosimilars-as-innovation argument well in his presentation, claiming, “The level of sophistication required to produce macromolecules from living organisms, while paying respect to quality attributes and minimizing costs, continues to drive our industry forward.”

Beyond technology, there also needs to be what Liang termed “regulatory innovation.” Europe not only established a biosimilar pathway before the U.S., but it already has more than 20 approvals under its belt. Liang also pointed out that a number of switching studies have been carried out in various countries in the EU. These steps emphasize how far the EU has come in the past 10 years. In the U.S., we’ve seen lots of progress made this year. Last year at this time, we had only one biosimilar approved. Now, with three more biosimilar approvals on our docket, we’re beginning to see more comfort with the abbreviated pathway. As Liang stated, the emphasis on molecular similarity in the last two FDA advisory committee meetings “is a step in the right direction toward regulatory innovation.”

How Manufacturers Can Improve Patient Access

The ultimate goal for the biosimilar industry is to see the same level of uptake that small molecule generics experienced in the ’80s. But in order for this to happen, the industry has to dedicate itself to bolstering patient access. “We have to determine whether we can achieve something similar to what we’ve witnessed in Europe,” explained Liang. “Can we double the number of patients who are treated with filgrastim after the advent of biosimilars? Can we actually provide direct patient services using the resources saved through biosimilar use?” To Liang, patient access should be on the industry’s mind constantly. And the best way to achieve this is to look at those who have come before the U.S. “Those in Europe know where the deepest holes in the road lie,” said Liang.

Beyond the approval of biosimilars, the countries in Europe can also stand as a model for how to communicate to the various stakeholders about the benefits of these biologics. The U.S. is at a critical juncture right now, with the looming presidential election and the continuing scrutiny on drug pricing. Therefore, one of the fights biosimilar makers have before them is ensuring they are recognized as part of the solution to high drug prices. This needs to be communicated clearly within all educational initiatives.

The problem, however, isn’t encouraging the industry to educate. I’ve frequently heard various stakeholders mention “education” as a top priority when it comes to biosimilars. But Liang sees manufacturers and researchers making a critical mistake in their communication. “This education has to be diverse and address all stakeholders. Most importantly, it has to address them in a language they understand.” It’s easy to talk about extrapolation, interchangeability, and analytical similarity between manufacturers. “But these conversations often occur in language that would not be understandable to anybody else in the room,” Liang argued. “It is our charge to make our perspective understood by all stakeholders. We have to be able to provide what our value-add is and articulate that clearly.” For instance, it’s being spoken more often that biosimilars are not only cost-effective for patients and healthcare systems, but they can also free up healthcare costs to cover the novel biologics coming to market. Despite the threat biosimilars pose to originators going off patent, their cost-effectiveness can help incentivize future research and development of innovative biologic treatments. This is something that needs to continue to be emphasized to stakeholders, especially policymakers so they are able to create supportive policies that foster a competitive market.

Overall, Liang’s charge to the industry can be broken down into three concise words: innovate, educate, advocate. Technology and science need to continue advancing in order for biosimilar makers to provide regulators with sophisticated analytical characterization of biosimilars. This will be key to ensuring regulatory flexibility which could reduce the number of preclinical and/or clinical studies required, in turn speeding patient access and uptake.

Though finding ways to communicate with such a diverse body of stakeholders could be daunting, a fledgling industry offers one important advantage. “We can help shape it,” said Liang. He quoted Socrates, “The secret to change is not to focus on fighting the old, but it’s on building the new.”

So far, the industry has been faced with fear-mongering that dates back to the ’80s during the launch of the first generics. But in 2016 alone, FDA approved several more biosimilars, ushering them closer to the market. As Liang said, looking beyond the U.S. to other nations is one way to inform our country on its own biosimilar journey. But it’s also important for all manufacturers targeting the U.S. market to have a say in shaping the market.