A Word From the Experts: The US Biosimilar Market Today and Onward

So far, 2020 has looked mixed for the US biosimilar market despite predictions of a business and regulatory boom for the year. Between the coronavirus disease 2019 (COVID-19) pandemic, regulatory changes, production halts, and approval delays, experts say there is still hope for the budding market for the remainder of the year and going forward.

Biosimilars in the COVID-19 Era

Although Will Gatziolis MBA, an associate principal at ZS, thinks that the US biosimilars market will continue to grow once the pandemic is over, he still believes that manufacturers need to make more efforts to step up their marketing and sales dynamics to take advantage of the situation.

Gatiziolis said that he thinks “what's going to be really important, and where this is becoming a very interesting discussion about the overall COVID-19 effect is [that] 2020 was about the setting up a long-term, fundamental marketplace for oncology biosimilars. The effects of COVID-19 are going to be interesting...”

Sarfaraz Niazi PhD, an adjunct professor of biopharmaceutical sciences at the College of Pharmacy at the University of Illinois at Chicago, remains very hopeful that the pandemic will ultimately be good for biosimilars as it highlights the need in the United States for more affordable medications. However, there are still some challenges that will impact approvals and clinical trials.

“Well, like every other business, everything is literally on hold today. Some companies have shut down totally, others [have] said they're working on it. There is no doubt in my mind that we are looking at a 6 to 9-month delay in everything they're doing, and I don't think anybody can deny that,” said Niazi.

Congressional Battles for Biosimilars

Ted Mathias and Stacie Ropka, patent attorneys and partners at Axinn, Veltrop, and Harkrider LLP, discussed the potential for the removal of the Affordable Care Act (ACA), which contains the Biologics Price Innovation and Competition Act (BPCIA) that functions as the framework for the biosimilars approval process.

As the Supreme Court prepares to decide whether to keep the ACA, separate the BPCIA from the ACA, or do away with both completely, manufacturers need to come up with a game plan in case the unthinkable occurs and uproots their biosimilar efforts.

“Now, it's possible that these biosimilar developers could try and seek approval under the traditional pathway, but that is, of course, going to require more regulatory hurdles, and because the patent dispute resolution pathway would no longer exist, the developer might be faced with launching any product at risk,” said Ropka.

Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM), discussed potential actions could take place if the ACA is deemed unconstitutional.

“Every time you revisit a piece of legislation, there are always opportunities for interested parties to try and leverage that and ask for more or ask for things that weren't clear to be taken away. So, it's a bit of a challenge and we're very hopeful that it will be severed,” Simmon said.

Additionally, she discussed the legislation advocates want Congress to pass to ensure a pathway and fair marketplace for biosimilars.

Ha Kung Wong, JD, an intellectual property law attorney and partner at Venable Fitzpatrick in New York, and April Breyer Menon, JD, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, discussed the likelihood of passage for some of the bills on the floor of Congress and who legislators will have to answer to.

“Regardless, the public is generally in favor of drug pricing initiatives. So, we may see legislators trying to push something through or at least provide some demonstrable progress as part of their bid for re-election or in support of their party. However, let's not forget the lobbyists, as many companies and groups that contribute to campaigns appear to oppose many of these bills, which may lead to limited congressional support,” said Wong.

The Future of the Biosimilar Market

Joseph Fuhr, PhD, professor emeritus of economics at Widener University in Chester, Pennsylvania, and an expert on antitrust health economics and pharmacoeconomics, elaborated on some of the current and future barriers to biosimilar uptake.

Overall, manufacturers are going to need to step up to compete against one another and to reckon with reference manufacturers. Fuhr said that, “biosimilars are a grand experiment. If competition doesn't work in this market, that is where the government will get involved and put in price controls.”

See all these interviews and more at centerforbiosimilars.com/interviews.