26/15/9: Biosimilars at the Crossroads

After a flurry of action in December and January, there has been comparatively little action on the biosimilar news front in the past couple of weeks. As a result, I was looking forward to refreshing the till with a visit to the World Biosimilars Congress 2020 in San Diego this week. And the meeting didn’t disappoint. Over the next few days, I’ll be gathering my thoughts for specific posts from the meeting and individual discussions with my colleagues and (new and old) friends, and what I learned and could retain from experts who know far more than me.

The sessions themselves provided the opportunity to consider the current status of the industry in the US: 26 approved agents, 15 launched biosimilars from 9 reference classes as of today. The 26 approvals is fairly impressive, and the number of biosimilars passing Food and Drug Administration (FDA) scrutiny over the past two years alone is impressive. Fifteen launches, however, is a frustrating number, the well-understood result of a difficult experience on the patent dance and litigation learning curve. The vast majority of the delays have involved adalimumab and etanercept—the two biologics that would benefit most from biosimilar competition.

Nine reference products is perhaps more telling regarding the future of the industry. According to Sarah Yim at FDA’s CDER, the FDA is consulting on 74 biosimilar development programs, many of which may involve biosimilar categories with existing competition. The FDA does not disclose information on its consulting program, other than total numbers. One may assume that several of these developmental programs involve insulins that will be evaluated under the 351(k) pathway after March 22. Comparing the number of biosimilar approvals based on reference products with that of the European Medicines Agency (EMA) is flawed. The EMA considered growth hormones, insulins, and other proteins as biosimilars from the outset, and the FDA is only doing this now.

In the future (near and distant), there will be ample anti-TNF inhibitors, interleukins, multiple sclerosis agents, checkpoint inhibitors, VEGF antagonists, and other immunotherapies that may be subject to biosimilar competition, assuming the industry is sustainable.

At the meeting, the overarching sense was that the industry is at a crossroads today. I term it using Winston Churchill’s description: “This is the end of the beginning.” Hopefully, not the opposite. The reason I believe this is that 10 years after promulgation of the BPCIA, those chosen to play in the biosimilar field and remain today seem to have a clearer understanding of where they would like to go and how they will get there. The number of patent lawsuits being filed today seems to be lower than the number of settlements. However, as Christine Simmons, Executive Director of the Biosimilars Council pointed out, we should not underestimate the ingenuity of patent lawyers—this may only be a trough in a cycle.

Barring a surprising, catastrophic decision in State of Texas v. USA, the underpinnings of the biosimilar framework may be getting stronger—in part due to actions at the federal level and bipartisan sentiment against high drug prices. Yet, this positive take is a bit fragile, partly because relatively few manufacturers have experienced success on the marketplace to date. In addition, too few manufacturers are currently among the active players in the US marketplace.

What does this mean going forward? How will the industry cross section be characterized in 2025? Will there be more players? Will we find eight companies selling adalimumab biosimilars or will that number be winnowed down to three or four? Which biologic reference drugs will be the next biosimilar success stories? And will anticompetitive behavior by reference manufacturers be a continuing concern or consigned to the past? I’m getting more optimistic and hope to be present for the unveiling beyond the crossroads.

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