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Biosimilars in the Pipeline


Several biosimilars will come to market within the next few years.

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“Biologics are innovative treatment options for patients affected by debilitating and life-threatening diseases; however, they are often associated with high costs and limited patient access. Fortunately, more affordable options for many patients who rely on biologic treatments are beginning to enter the market: biosimilars,” reads an excerpt from, Why Biosimilars Are Important for Patients, published in February 2018 by the Biosimilars Council, a division of the Association for Accessible Medicines. “The launch of new biosimilars over the next decade could save consumers as much as $250 billion and boost access to biologic treatments for an additional 1.2 million patients by 2025,” according to the article.

U.S. drug spend and utilization for biosimilars has steadily increased year after year, says Managed Healthcare Executive® Editorial Advisor David Calabrese, RPh, MHP, senior vice president and chief pharmacy officer, OptumRx.

From 2017 to 2018, spending grew from $46 billion to $54.1 billion.

For this review, Calabrese provides information for products that have not had a previous biosimilar launch. The top five drugs that have biosimilars in the pipeline, he says, are: Humira, Enbrel, Lucentis, Actemra, and Eylea.

1.  Humira (adalimumab). Humira is prescribed to treat rheumatoid arthritis, chronic plaque psoriasis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-infectious uveitis.

“Humira has been the number one selling drug for many years, and its costs has risen dramatically over the years, about $19,000 a year in 2012 to more than $38,000 today,” Calabrese says.

Related: 3 Ways Insurers Can Help Promote Biosimilar Adoption

Five biosimilars for Humira have been FDA approved within the past three years. The first to receive approval, in 2016, was Amjevita (adalimumab-atto) for the treatment of seven inflammatory diseases. Cyltezo (adalimumab-adbm) was approved next, in 2017, followed by Hyrimoz (adalimumab-adaz), which was approved in 2018. In July 2019 the FDA approved a fourth biosimilar, Hadlima (adalimumab-bwwd), for all eligible indications of the biologic product. And in November 2019, Abrilada (adalimumab-afzb) was approved. All of these biosimilars are expected to launch in 2023. There are six more companies with biosimilars in phase 3 trials, according to Calabrese.

2.  Enbrel (etanercept), a drug licensed in 1998, is prescribed for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Two biosimilars are coming to market: the first, approved in August 2016, is Erelzi (etanercept-szzs). The second, Eticovo (etanercept-ykro), was approved in April 2019. Both drugs have a launch date of 2H 2020 or possibly 2029. Patent litigation is ongoing and 2029 appears to be the more likely launch date, however there is still a small chance that court judgment could favor the biosimilar manufacturer enabling a 2020 launch, Calabrese says. There are two more companies with biosimilars in phase 3 trials.

3. Lucentis (ranibizumab) will have three biosimilars on the market, all currently in phase 3 trials: FYB201, Xlucane, and SB11. Lucentis is used to treat wet age-related macular degeneration; diabetic macular edema; macular edema following retinal vein occlusion; diabetic retinopathy; and myopic choroidal neovascularization.

4.  Actemra IV (tocilizumab) is used alone or with other medications to treat moderate to severe rheumatoid arthritis, which affects about 1.3 million U.S. adults. In addition to rheumatoid arthritis, tocilizumab is also indicated to treat giant cell arteritis in adult patients, polyarticular juvenile idiopathic arthritis, and juvenile idiopathic arthritis. BAT1806 is a biosimilar in phase 3 trials. The manufacturer plans to file for approval in 2021, with a release date of July 2022 or later.

5.  Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of wet age-related macular degeneration; diabetic macular edema; macular edema following retinal vein occlusion; diabetic retinopathy. The biosimilar MYL-1701P, is in phase 3 trials, with plans to file in the first quarter of 2021, with a release date of 2023.

Tricia Krizner is a Cleveland-based writer.

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