A Holistic Approach is Crucial for Biosimilar Uptake

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

As Brill sees it, there are 4 main categories of barriers to biosimilar uptake: reference product manufacturers, biosimilar manufacturers, policy, and education.

In terms of reference product manufactures, Brill noted that drug developers have put up hurdles to biosimilar uptake in the form of their rebate practices. “Certain reference product manufacturers have conducted aggressive strategies with payers where if a payer were to put a biosimilar on its formulary, it would lose the rebate discount provided by the reference product,” said Brill.

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The solution, he says, comes down to which stakeholder group is being addressed. For payers, he recommends adopting a longer-term perspective when negotiating contracts and designing formularies. For employers, he said the key is to identify cost-saving opportunities for their businesses as well as for their patients. Finally, for drug makers, he said that manufacturers need to ensure fair market access for biosimilars.

Certain barriers to uptake are also “natural” as Brill puts it, such as market uncertainty for consumers and biosimilar manufacturers alike. “These products are expensive and take time to develop. There’s also a lot of uncertainty with regard to other competitors…how many other people are pursuing access to the same market for the same reference product?”

In addition, biosimilars have seen relatively limited market share thus far, which could potentially be due to discounts not being sufficient. To address these challenges, payers should institute policies to drive greater biosimilar utilization, and likewise, manufacturers need to be able to offer competitive contracting terms.

As far as policy is concerned, Brill believes the United States is moving in the right direction. The recent changes on the payment front from CMS were positive steps, but there remains more to do. “There’s an opportunity right now for relevant agencies to reevaluate the market and make sure that there are not unnecessary barriers that they’re imposing on this market,” he said.

Challenges such as the “patent thickets” that have been created, wherein a reference product developer looks to protect itself from competition by registering more patents, is something that law makers will need to address and hopefully do away with, according to Brill.

Finally, one of the biggest challenges to biosimilar uptake is the lack of stakeholder education and awareness. There is currently very limited prescribing experience, and healthcare providers have largely remained hesitant when it comes to prescribing these products to patients. Education should be provided not only to the patient and to the physician, but to the payers as well so that every stakeholder understands the what the product is, how it works, and how it should be paid for.

“No one challenge is any worse than another, but it needs a holistic approach of working across these barriers. Patient groups, industry, physician groups, and the FDA itself can play an important role in educating and informing the market,” said Brill.