Biosimilars: Some Call for ‘Cautious Optimism’

Biosimilars Approved in 2019

While there is debate about the size of the U.S. biosimilars market and its ability to trim drug costs overall, a leading consulting group calls for "cautious optimism" about biosimilars' potential to reduce costs.

The Advisory Board’s Lindsay Conway, managing director of Pharmacy Executive Forum, and Pam Divack, an analyst of Life Sciences, say that the successful evolution of the biosimilar market is going to take “targeted efforts to alleviate legal, regulatory, and operational hurdles.” The Advisory Board team made the comments following two high-profile Wall Street Journal op-ed pieces by Peter Back, director of the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center and Mark Trushheim, of the MIT Sloan School of Management. That was followed by a rebuttal on the future of biosimilars by former FDA Commissioner Scott Gottlieb. 

The Advisory Board opted to emphasize two key issues surrounding the success of biosimilars, including:

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The U.S. biosimilars market still needs time to develop. Gottlieb’s point is that it took more than 20 years for generic small-molecule drugs to capture 87% market share. Therefore, more investment in research and physician education is extremely important.

The U.S. healthcare industry can learn from Europe’s gains in efficiencies. “Any lessons or scale efficiencies we can glean from global markets seem worthwhile, and, even more so, are likely to advance efforts toward broader U.S. adoption and lower biosimilar prices,” Conway and Divack say.

Successes noted in Europe lead to other relevant questions too.

• What if we could lower the cost of biosimilar development by sharing (and accepting) trial data with other countries? 

• What if their real-world evidence can expedite our learning about bioequivalence, matching the right patient to the right treatment, and appropriate use? 

• Could we replicate their best practices for educating physicians about biosimilars and safeguarding against prescribing errors?

“Biosimilars create new financial, operational, and patient safety considerations-all of which must be addressed to ensure adoption,” Conway and Divack say.

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“Perhaps the most significant is inconsistencies in payer coverage. While some insurers have expressed preference for biosimilars, given their lower list prices, they have made coverage decisions on a drug-by-drug basis in practice (seemingly based on rebates or other arrangements with the drug manufacturers). As a result, providers must factor individual patients’ coverage into prescribing decisions or they risk losing reimbursement and saddling patients with unaffordable costs.” 

For more information and access other posts on biosimilars and generics, go to www.advisory.com/daily-briefing/2019/09/05/biosimilars.