The Obstacles That Impede Biosimilars

Drug Topics JournalDrug Topics February 2018
Volume 162
Issue 2

Hurdles to adoption of biosimilars include regulatory issues and lack of interchangeability with the reference drugs.

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Obstacles continue to impede the full adoption and acceptance of biosimilars, according to a new report published by the HDA Research Foundation.

"The U.S. market for biosimilars has been slower to develop than that of many other developed countries due to the slower pace of a supporting regulatory framework," say the authors of the white paper, Biosimilars: The State of the U.S. Market.

They identified reasons for the slow adoption such as a lack of provider awareness and acceptance of biosimilars, an uncertain return on investment, a lack of interchangeability with biologics, coding concerns, and on-going patent litigation.

The report was compiled after conducting a series of interviews with U.S. specialty distributors and pharmaceutical manufacturers, as well as evaluating research on biosimilar policies and trends.

It highlighted the current biosimilar market, challenges that continue to face the industry, and potential strategies to improve awareness among healthcare professionals and patients.

Related article: Biosimilars Have Entered the Market, But Are They Safe?

The first biosimilar in the United States, Zarxio, launched in 2015. Another five biosimilars received FDA approval by August 2017.

Drug manufacturers continue to see tremendous opportunity within the market for biosimilars, particularly as six of the top 10 U.S. biologic drugs are expected to lose patent exclusivity by 2019.

The biosimilar market remains small, with only three biosimilars reaching the market as of August 2017. However, new biosimilar products continue to flood the drug pipeline with an estimated 700 biosimilar products in development worldwide.

Biosimilars have the potential to provide more therapeutic options for patients with complex diseases and could lower healthcare costs. The delay could be in part due to the length of time it's taken to establish a clear regulatory pathway.

According to the report, discussions about a biosimilar approval pathway in the United States first began in the 1990s, but it wasn't until 2010 that a separate pathway was started through the 2010 Biologics Price Competition and Innovation Act.


Since then, the FDA has provided guidance on the regulatory, scientific and quality considerations to be used for biosimilars, and naming standards.

The FDA released draft guidance in 2017 on the data needed to support interchangeability between a biosimilar and its reference biologic; but no biosimilar has achieved interchangeable status.

Once a biosimilar is ready to launch, there are still unique challenges for the industry.

Related article: How New Biosimilars Will Impact the Market

One of the biggest is a lack of awareness and acceptance of biosimilars among providers. For instance, a recent 2016 study noted in the HDA report found that, while a survey of provider perceptions indicated that 57.2% of respondents believed a biosimilar would be at least as safe as the reference product, a significant 42.8% disagreed with that statement.

Manufacturers and distributors believe that education efforts need to be started early to improve acceptance of biosimilars.

"While several biosimilar drugs are now available in the U.S., these products only are available for a small number of therapeutic areas, so most specialty providers have yet to have the option to prescribe a biosimilar drug to treat a patient," the report stated.

The report stressed that education efforts begin with general information about how biosimilars are produced, how they are approved, and the evidence needed for determining interchangeability with the reference product.

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