From The Editor | December 9, 2016

Congress Takes On Biosimilars

Source: Biosimilar Development
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By Anna Rose Welch, Editor, Biosimilar Development
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This week, I watched a livestream of “The Next Drugs: An Atlantic Policy Briefing on Biosimilars,” held by The Atlantic and underwritten by The Biosimilars Council. The briefing included interviews with a U.S. senator and a congressman, as well as a panel discussion with experts from Amgen, Sandoz, the American Diabetes Association, and Foley & Lardner LLP. While the final panel discussion is definitely informative and worth watching, I was particularly interested to hear the interview of Senator Bill Cassidy of Louisiana. The senator, who will play an influential role in the future of the Affordable Care Act (ACA) and Biologics Price Competition and Innovation Act (BPCIA), presented some valuable insights into where he believes more work needs to be done to ensure biosimilars’ market success.

Are There Changes On BPCIA’s Horizon?

Senator Cassidy is likely to be a valuable asset when it comes to biosimilar policy. He not only brings a legislative perspective to the table, but he is also a gastroenterologist. During the briefing, he demonstrated a sound knowledge of biologics and biosimilars (as we would all expect him to), and he drew upon his experience working with patients who will, no doubt, encounter biosimilars in the near future.

There have been many questions about what will happen to the BPCIA after President-elect Donald Trump takes office in January. At this point, it’s unclear whether the BPCIA would also be eliminated if the ACA is repealed, if it would be significantly revised during an overhaul of the law, or if it would simply be left as is.

Cassidy expects the BPCIA will be one of the pieces of legislation carved out of the ACA. After all, “When people think of Obamacare, they’re thinking of skyrocketing premiums and the government telling them what to do,” explained Cassidy. “They’re not thinking, ‘What are we doing with follow-on biologics?’”  

That said, however, when asked if there would be any changes to the BPCIA, he admitted he’d have to go back through the legislation with a “fine-tooth comb” to sufficiently answer that question. This obviously leaves the door open for potential changes within the BPCIA legislation itself, regardless of what happens to the ACA.

He did call attention to the FDA’s slow progress putting together the statistical analysis and interchangeability guidances, both of which were promised this year. In particular, he emphasized the importance of the statistical analysis guidelines in order to ensure a company’s biosimilar fits within the appropriate statistical variability parameters. At an oversight hearing with the FDA’s Janet Woodcock in December 2015, Woodcock said the statistical guidance would be out within six months. “The drugmakers are saying they need to know this, and it has been almost a year since we were given that deadline, which wasn’t met,” he said. “In that sense, the BPCIA is not working the way it should be.”

Of course, he acknowledged the importance of ensuring the safety of biosimilars so the market gets off on the right foot. “Are these delays understandable and acceptable for the short term? Perhaps,” Cassidy offered. “But we’d really like to see what was promised to us eight or nine months ago available sooner.”

The Importance Of Big Data For Interchangeability

Like many biosimilar industry experts, Cassidy emphasized the importance of looking at Europe’s biosimilar experiences for reassurance about the interchangeability of biosimilars. After all, Europe has been using biosimilars for the past 10 years, and the switching data coming out of these nations does a good job portraying the safety of biosimilars. What I found particularly refreshing about Cassidy’s discussion on interchangeability was his acknowledgement of the differences that also exist from lot-to-lot of reference drugs — a statement we rarely hear addressed by brand companies, let alone physicians.

In fact, Cassidy approached biosimilar interchangeability very frankly. “Life being life, not everyone goes from drug A to drug B and stays on drug B forever,” he said. “Inevitably, someone will be swapped from drug A to drug B and then back to drug A.” (The diabetes space is a great example of the dance among drugs A, B, and C. As Robert Ratner, CSO and CMO of the American Diabetes Association, explained in the panel discussion, formularies have often required diabetes patients to switch amongst several different, branded insulins. And, more important to note, many of these insulins, especially the longer-acting treatments, are not equivalent or interchangeable.)

The real task at hand for the U.S. is finding a way to establish biosimilar interchangeability without having to carry out additional lengthy and expensive trials. “We have to learn how to best use Big Data and post-market surveillance,” explained Cassidy. “Can we look at countries that already have experiences with interchangeability and do post-marketing surveillance to get a sense of how well it’s tolerated?” Ultimately, he argued, there needs to be a better way to determine a biosimilar’s efficacy and interchangeability than a multi-arm crossover trial that will take years.

Overall, I’d urge you to carve out an hour and a half of your day to watch all three segments of this briefing in full. In my experience, it’s rare to hear senators discussing their perspectives on biosimilars (outside of the occasional biosimilar-related Senate committee hearings). Cassidy approached the topic thoroughly, blessed with both political and medical experience.

But it was also reassuring to hear a gastroenterologist — a field which has voiced many concerns about biosimilar extrapolation — speak confidently about the interchangeability of biosimilars. As Cassidy described at the beginning of his discussion, biologics have been revolutionary for the treatment of chronic disease. He’s optimistic biosimilars will be able to carry on their legacy for even more patients at a lower cost. But it will come down to keeping certain fears in check, as well as growing comfortable with relying on post-market surveillance to learn more about a biosimilar’s performance over time.  

“We can be consumed by existential anxiety,” he said. “That which we do not know strikes such fear in us, we never advance. There’s an incredible opportunity cost there, because otherwise we’d never have these advances that keep Crohn’s patients, for example, from continually going to the hospital. We have to make sure that we don’t miss out on this opportunity to medically advance as we try to ensure the safety of biosimilars.”