Opinion On FDA's Biosimilar Review Pace "Depends On Where You Sit"
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Earlier this week, I published an article based off the most recent AtlanticLIVE policy briefing on biosimilars. This event, put together by The Atlantic and The Biosimilars Council, featured an interview with Representative Michael Burgess, who shared his views on the “need for speed,” if you will, in the Biologics Price Competition and Innovation Act (BPCIA) regulatory pathway. But I also felt the second half of this event, a panel discussion among experts from biosimilar maker Apobiologix, the American Cancer Society, and the law firm Hogan Lovells, was worth unpacking.
Burgess emphasized Congress’ wishes to see more approvals and market launches over the next five years of the Biosimilar User Fee Act (BsUFA II). This was certainly a desire expressed by all three members of the panel. But each expert also brought a variety of different experiences and relationships with biosimilars, and, as such, different feelings about the rate at which this market is taking shape.
Unpacking Stakeholder Responses To Regulatory Differences
It seems there’s never a shortage of good discussion around how the U.S.’ and EU’s regulatory agencies differ in their approaches to biosimilars. While the EU has had 10 years of experience (with uptake varying drastically from country to country), the FDA has earned the reputation of being quite conservative. This conservatism can be seen, for instance, in the recently released interchangeability draft guidance, which spared no challenges for drugmakers in establishing that extra proof of similarity.
As Jim Van Lieshout, the VP of market access and pharmacy strategy for Apobiologix, discussed, there is a lot of emphasis on how the biosimilar approval process is, and must continue to be, streamlined to bring these cost-effective drugs to market efficiently. But demonstrating interchangeability is a contradiction to the abbreviated approval process because it’s “an add-on process,” he said. “The U.S. is the only place in the world that’s currently attempting to regulate interchangeability,” and, as such, there are a number of unique challenges for drugmakers wishing to pursue interchangeability.
Another difference between the U.S. and the EU has to do with the approach regulators take toward working with biosimilar makers. One of the differences David Fox, a partner at Hogan Lovells, mentioned was the European Medicines Agency’s (EMA’s) reliance on class-wide guidances. While the FDA also releases guidance for the industry, it seems the agency and biosimilar companies have more heavily emphasized the U.S. regulator’s meeting process with applicants.
“The U.S. picked a resource-intensive approach, in which they negotiate with individual sponsors on product-specific scientific issues,” Fox described. The agency and industry has defended this in-depth approach to product development because there is still a lot to learn in the realm of biosimilars. However, Fox surmised another reason behind establishing this time-consuming meeting process was potentially shortsighted. “I think in the U.S., there were concerns that innovator companies would get too involved in the biosimilar programs, so the FDA tried to shield that,” he said. “But we might look back someday and think that this process consumes too many resources and isn’t efficient.” (I’m a little disappointed his answer was not explored more fully, especially considering the fact many of the leaders in the biosimilar space today are the large innovator companies.)
Now, this isn’t to say there aren’t opportunities for drugmakers to work with the EMA on scientific issues. The EMA launched a new pilot program in February 2017 to provide tailored scientific advice to companies developing biosimilars. There are also parallel scientific meeting opportunities for companies to work together with the EMA and FDA in cases where more scientific alignment between the agencies is needed.
Differing Perceptions Reveal Split Between Industry, Political Administration
Ensuring a company does as much as is necessary to ensure an approval — but not more than necessary — has been a topic of much discussion during FDA panels at U.S. conferences over the past year. As more biosimilar companies begin working with the FDA, members of the agency have emphasized taking a stepwise approach to drug development. Depending on the data the company already has, the FDA may determine fewer studies are needed to demonstrate similarity.
Though the current political administration may find the meeting/approval process too lengthy, Van Lieshout was quite supportive of the FDA’s stepwise approach. “This stepwise approach may take longer, but it makes sure manufacturers are getting it right,” he said. “After all, the government and all other biosimilar stakeholders want to ensure that everything is correct, safe, and effective.”
Congress’ emphasis on seeing quicker approvals was also tempered by Len Lichtenfeld, deputy CMO of the American Cancer Society. As he mentioned, the whole conversation about the FDA and speed of approvals “depends on where you sit.” The oncology society for the most part has been very pleased with what the FDA has done to bring cancer drugs to the market more efficiently. As he described, “We know the pace of FDA drug approvals has been labeled an issue in Washington. But from our perspective, we’re pleased by what we’ve seen in the oncology space.” In particular, he singled out the FDA’s willingness to have conversations with regulators abroad and to take that information into consideration. He expressed hope this will continue into the future.
At the House Energy and Commerce Committee meeting a few weeks ago, Congress was urged to reauthorize BsUFA II and to push for a resolution to the current hiring freeze to ensure quicker review cycles. But it was particularly valuable to learn just how differently the multiple stakeholders and experts in this space view the pace at which the industry is developing. In fact, I’d argue the biosimilar industry and the current political administration are on different pages when it comes to market expectations.
As Fox described, it took 10 years for the FDA to finalize the Hatch-Waxman regulations, and it took until the late ’90s — roughly 15 years later — for the major court cases to be settled. There were some Supreme Court cases early on in the start of the generics industry, as well. As everyone in this space no doubt knows, the biosimilar industry itself is on the brink of a Supreme Court case next month on the patent dance and the 180-day notice of commercial marketing issues. To Fox, this is actually a sign the industry is where it needs to be at this time.
“I think some of the key disputes on the intersection between the science and IP have actually risen through the courts quite quickly,” he said. “So progress may seem glacial, but by lawyer and FDA standards, this market is actually moving at the appropriate pace.”