What Can US Learn About Biosimilars From Europe?

Europe has several lessons for the US biosimilar market, according to a pharmaceutical executive who spoke during ISPOR 2019.

Europe has several lessons for the US biosimilar market, according to a pharmaceutical executive who spoke during ISPOR 2019.

“You need to have a balance so that there is sustainability in the marketplace,” said Chad Pettit, the executive director of Global Value Access and Policy for Amgen’s Biosimilars Business Unit.

Asked to elaborate in an interview with The Center for Biosimilars® after the panel discussion about biosimilars, he indicated that he meant the different systems that European governments have for reimbursement.

The United Kingdom, for example, has a multi-winner tender system, but other countries, he said, have what he called more extreme procurement mechanisms, such as single tender, winner-take-all systems. Particularly in smaller companies, procurement is “extreme,” he said.

“A single tender procurement mechanism really creates an unbalanced end result,” he said, “creating short-term wins for the country but it’s probably not a long-term win.”

In the United States, CMS set what he called a level playing field for Medicare Part B, but he was more critical of CMS’s decision to reimburse biosimilars differently in the 340B program for hospitals. “We think that that is a distortion of the marketplace and in the long run is not going to benefit the marketplace overall," he said.

During the panel at ISPOR, participants spoke about the need for continued education of physicians and patients. Pettit said overall Amgen was pleased with the FDA’s educational efforts so far, and said all groups play a role, including physician groups, patients groups, medical societies, pharmacists, health plans, and manufacturers. But ultimately, it is the FDA that possesses most of the influence, he said.

Amgen believes that 3 pieces are needed for a long-term market: scientifically appropriate regulatory standards, a level playing field, and scientifically accurate educational outreach.

Asked about the beliefs of different patient groups, with some more in favor of biosimilars than others, Pettit said that gets back to the need for scientifically accurate education. Noting that different groups have different levels of confidence, some might ask questions relating to development, supply, manufacturing, the approval process for prescribing, extrapolation, switching studies between an originator product and its reference product, the difference between a product approved as a biosimilar and a product approved as an interchangeable biosimilar, and pharmacovigilance.

The FDA final rule on interchangeability “gives us certainty on our development programs," he said. "It allows us to have a clear view as we think about development of biosimilar medicines.”

During the panel, he mentioned the cost savings that biosimilars are expected to provide, citing an IQVIA report that said biosimilars saved $7 billion this year and predicts that further use will generate $60 billion in savings by 2023. Those savings "are evidence that the system is working," he said afterwards.

Pettit appeared on the panel with Ha Kung Wong, JD, MBA, a patent attorney with Venable Fitzpatrick, who provided an overview of the post grant review (PGR) and inter partes (IPR) review procedures, which are used for challenging the validity of patents at the patent office, as opposed to more expensive district court litigation.

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