Biosimilar drugs can reduce costs but still face challenges in the US

November 04, 2019

Biologics used to treat patients can be incredibly expensive, so there was significant hope that biosimilar drugs -- which are highly similar to an existing biologic drug on the market -- could serve as a less-costly substitute. However, new research from the University of Minnesota and Mayo Clinic finds that while physicians are indeed willing to prescribe these drugs, the cost savings are minor and there remains a number of regulatory barriers to their use.

The research, led by Professor Pinar Karaca-Mandic with the Carlson School of Management, was funded with a grant by the American Cancer Society and was published in the November issue of Health Affairs.

First available in the U.S. after the passage of the Affordable Care Act and its Biologics Price Competition and Innovation Act (BPCIA), biosimilars are biological drugs that are highly similar to another biologic. The concept is somewhat like generic versions of brand name drugs, but biologics and their biosimilars are much more complex than non-biologic medications. The BPCIA allows biosimilar manufacturers to use data from the original product's approval application to establish the safety and effectiveness of the drug. The first approved biosimilar product in the U.S. was filgrastim-sndz. Based on filgrastim, it is used to prevent and treat a condition called neutropenia (i.e., a low number of a type of white blood cells). However, prior to filgrastim-sndz's launch, tbo-filgrastim was approved in Europe as a biosimilar to filgrastim. In the U.S., because there was no approval process for biosimilars, it was introduced here as a "related drug substance," though its uptake rate was low.

Previous research showed that filgrastim uptake declined 40% among Medicare patients after the introduction of filgrastim-sndz, but there was little information available to know if patients on private insurance or Medicare Advantage plans were also seeing declines in filgrastim uptake. In addition, the study noted the way commercial insurance reimburses for prescription drugs sometimes disincentivizes the use of lower-cost products.

Using anonymized claims billing data from commercial and Medicare Advantage insurance plans, researchers identified how many patients were prescribed and how much they paid for filgrastim, filgrastim-sndz and tbo-filgrastim.

The study found:Filgrastim makes for an interesting case study because of how market responses differed between tbo-filgrastim, the European biosimilar approved under the biologics license, and filgrastim-sndz, according to Molly Moore Jeffery, a study co-author and research associate in the Department of Health Sciences Research at Mayo Clinic.

"We found that the market share and price of the originator drug didn't respond much to that new entrant," says Jeffery, who is also the scientific director of research in emergency medicine at Mayo Clinic. "It wasn't until the official U.S. biosimilar was approved that we saw a big shift away from the originator drug. It will be interesting in future work to understand how doctors and patients perceive biosimilar safety and effectiveness and how that drives the market for biosimilars."

The biosimilar market is one to watch, as it offers both promise and challenges ahead, according to Karaca-Mandic.

"Biosimilar uptake was fast, and there were cost savings," she says. "However, there are still major barriers. For example, there are legal battles by originator biologics that delay the entry of biosimilars. In addition, originator biosimilars offer rebates to health plans to cover originator biologics as the preferred drugs in the health plan coverage policies."
-end-


University of Minnesota

Related Mayo Clinic Articles from Brightsurf:

Mayo Clinic-led study links obesity with pancreatitis
A study by researchers at Mayo Clinic in Arizona published in the The Journal of Clinical Investigation has found that obesity is not only implicated in chronic diseases such as diabetes, but also in sudden-onset diseases such as pancreatitis.

Mayo Clinic researchers clarify how cells defend themselves from viruses
A protein known to help cells defend against infection also regulates the form and function of mitochondria, according to a new paper in Nature Communications.

Mayo Clinic study looks at changes in outcomes for coronary revascularization
The most common type of heart disease -- coronary artery disease -- affects 6.7% of adults and accounts for 20% of 2 in 10 deaths of adults under age 65.

Mayo Clinic researchers review modern cases of leprosy
Leprosy has a history that has spanned centuries and societies across the globe.

Kidney stones on the rise, Mayo Clinic study finds
Kidney stones are a painful health condition, often requiring multiple procedures at great discomfort to the patient.

Mayo Clinic researchers demonstrate value of second opinions
Many patients come to Mayo Clinic for a second opinion or diagnosis confirmation before treatment for a complex condition.

Mayo Clinic researchers clarify chemo resistance, and perhaps a new therapy
Mayo Clinic scientists have identified a specific protein implicated in drug resistance, as well as a possible therapeutic tool.

Mayo Clinic researchers identify therapy
Mayo Clinic researchers have found that an experimental drug, LCL161, stimulates the immune system, leading to tumor shrinkage in patients affected by multiple myeloma.

Mayo Clinic researchers uncover new agents
Mayo Clinic researchers have uncovered three new agents to add to the emerging repertoire of drugs that aim to delay the onset of aging by targeting senescent cells -- cells that contribute to frailty and other age-related conditions.

Mayo Clinic: Reversing physician burnout, using nine strategies to promote well-being
Researchers at Mayo Clinic have been documenting the rise and costs of physician burnout for more than a decade.

Read More: Mayo Clinic News and Mayo Clinic Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.