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FDA Biosimilar Approval Pace Picks Up


With a couple of recent biosimilar approvals, the FDA has vastly improved on the pace from the first 5 months of this year, during which no biosimilars were approved.

The approval of a new adalimumab biosimilar this week does not change the fact that adalimumab biosimilars won’t be on the market in the United States for a couple years longer, but it does signify that the FDA is not completely stymied by its need to focus on treatments for coronavirus disease 2019 (COVID-19).

The approval of Hulio, a drug developed by Fujifilm Kyowa Kirin Biologics and commercialized in multiple countries by Mylan, marks the second biosimilar approved by the FDA in as many months, following the FDA clearance received in June for Pfizer’s pegfilgrastim biosimilar Nyvepria. It brings the grand total to 2 approved biosimilars for 2020.

This is well behind the pace from last year, which set a record of 10 biosimilar approvals, half by the midyear point. The first biosimilar (filgrastim, Zarxio) was approved in 2015. Subsequently, there were 3 approvals in 2016, 5 in 2017, and 7 in 2018.

With this week’s approval, the total number of US-approved biosimilars is now 28, and the number of commercialized biosimilars is 17.

In a release issued today about the adalimumab approval for Hulio, Mylan noted that although AbbVie’s Humira reference product is well protected with patent exclusivities, there is an agreed-upon scheduled launch date for Hulio, July 31, 2023. There are 6 approved adalimumab biosimilars in total and several others in the works. Biosimilar development companies have been settling with AbbVie over specific 2023 launch dates, but none of these drugs for rheumatoid arthritis and similar conditions would reach the marketplace before that time.

“This approval represents yet another date-certain launch opportunity and demonstration of our commitment to expand patients’ access to medicine thanks to the power of our global platform, including our global reach and scale, our continued demonstration of scientific excellence, and the benefits of strategic partnerships, such as the one we are proud to have with Fujifilm Kyowa Kirin Biologics,” Mylan said in its statement.

The approval for Hulio was based on the phase 3 clinical study ARABESC, which demonstrated no clinical meaningful differences in safety, efficacy, and immunogenicity for the biosimilar compared with the originator product. Hulio is indicated for patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

The FDA has previously stated that COVID-19 has placed huge strain upon its resource structure and necessitated a realignment of priorities; however, it has attempted to keep normal operations moving forward and, in recent months, has worked to ensure that adequate funds, raised through user fees for biologics license applications, are available to meet these responsibilities.

Previously the agency has documented problems with revenue and needs misalignment that have made it necessary to downsize activities to make available funds last. Lack of a disclosure policy at the FDA regarding biosimilar candidates under review makes it difficult to pinpoint the robustness of the pipeline or determine the extent to which COVID-19 has caused biosimilar approvals to stall.

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