Can the Biosimilar Market Achieve Long-Term Sustainability?

During the first day of the SMi Biosimilars Meeting held in Iselin, New Jersey, from November 14-15, 2018, Christina Yunis, global biosimilars market development lead at Pfizer, discussed the sustainability of and challenges seen in the biosimilars market from an industry perspective.

“Approval is only 1 challenge, then there are the differences seen in the regulatory perspectives provided by the FDA versus the [European Union], patent challenges, building provider and patient confidence, and battling misinformation,” said Yunis.

While various government agencies, such as HHS and the FDA, have put out documents looking to answer questions about driving biosimilar uptake, more still needs to be done. Yunis echoed what much of the marketplace deems as the ultimate goal of the biosimilar market: achieving long-term sustainability.

As of today, there are 14 biosimilars approved in the United States, though only 6 are available on the market with Pfizer’s epoetin alfa biosimilar, Retacrit, being the latest product, announced the morning of Yunis' presentation.

“Before achieving long-term sustainability, we need to first discuss the state of the market today. There are many hurdles to overcome­—contracting and intellectual property hurdles, regulatory and legal challenges, lack of clinical experience, pricing and reimbursement challenges, and misinformation in the marketplace,” said Yunis.

One of the main challenges that Yunis finds surprising is the many different insurance coverage plans that exist that either do not cover a biosimilar or only cover the biosimilar after a patient has failed on the reference product.

“When you think of the medical perspective, why on earth would you prescribe a biosimilar to a patient that failed on the reference product? This is clearly blocking coverage of the biosimilar,” she said. In fact, this is a common condition listed in some insurance plans, and is an issue going through the courts today as seen in Pfizer v. Johnson and Johnson.

Around challenging information in the marketplace, Yunis explained that when there’s a lot of confusion, physicians go back to what they know. For its part, the FDA has recognized this confusion and looked to address it through various education efforts such as educational videos, pamphlets, and documents.

However, sometimes too much information can be overwhelming. “One of the challenges we’re seeing now is information overload. I was in a meeting last week with some patient advocacy groups that told us that, it’s not that they didn’t have enough information, it’s that they had too much,” she said. To counteract this, Yunis said that we need to make it simple, with a reliable source of information where patients and providers alike can go and make informed decisions.

Although she conceded that she may not have the final solution, she believes “we have a responsibility to address the misinformation in the market, and instead maintain a consistent message across the board.”