Adopting Biosimilars in the US: Overcoming the Obstacles

Philadelphia, PA—Europe and other countries lead the United States in bringing biosimilars to market, according to Steven Miller, MD, vice president, chief medical officer, Express Scripts. “The US is falling behind in an area that could improve access and affordability of life-changing medications for patients who most need them,” he noted during a session at Biosimilars 20/20.

Dr Miller and Robert Stianchi, PhD, director of biosimilars market research, Merck, spoke on the obstacles and challenges of bringing biosimilars to the US market.

The first major obstacle was the lack of an approval pathway, said Dr Miller. The Affordable Care Act helped make the approval pathway a reality, and paved the way for the first FDA-approved biosimilar in February 2015 (ZarxioTM), yet it remains unavailable due to ongoing litigation between its manufacturer and the maker of the branded drug (Neupogen®).

The second hurdle, said Dr Miller, is to ensure easy and affordable access. He called for clear rules on interchangeability, naming, and education.

Dr Stianchi noted that biosimilars, like biologics, are complex scientifically and market-wise. Among the challenges of implementing biosimilars are defense strategies by makers of the originator biologics, such as rebates and patient support and assistance programs.

Using what he called the “Parenthood Theory” to describe the challenge of implementing biosimilars in the already established biologics market, he pointed out that the manufacturers of originator biologics have had many years to gain experience with their product and customers, and to gradually build on indications.

“They’ve been able to grow and learn along the way, in many cases providing a sophisticated total offer of product, service, and support,” he said. “For biosimilars, they must provide a total offer that is on par with that originator immediately; they will not have years to learn and develop.”

Further, he said, “Customers have come to expect a certain level of service and support, and biosimilars will need to develop a service and support portfolio that is not just biosimilar but also ‘market similar’ at the time of launch.”

Emphasizing the cost savings with biosimilars, Dr Miller said that in the European Union, biosimilars are about 30% less than their branded originators and have the same efficacy and safety.

“The US can save more than $250 billion over the next 10 years from just 11 biosimilars being approved and coming to market,” he said, adding that these medications can make a meaningful difference in the lives of patients, particularly those with cancer.

Other than ZarxioTM, there are currently 4 near-term biosimilars in the pipeline, according to Dr Stianchi. They are InflectraTM, pegfilgrastim, GrastofilTM, and Retacrit®.

Despite the cost savings, it is not clear how biosimilars will be treated in formularies in the US. According to Dr Stianchi, formularies will need to consider and evaluate “how an individual biosimilar should be positioned relative to the reference originator product; as well as other biosimilars against the same reference originator, other class originator, and biosimilar products.”

Dr Miller said that for payers and patients to realize the full cost-savings of biosimilars, the process of delivering these medications must be clear and simple without generating confusion, concern, or delays in receiving the medications.—Mary Beth Nierengarten