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Biosimilars Regulatory Roundup: August 2022


August brought with it 2 regulatory approvals for ophthalmology biosimilars, an FDA approval for a high-concentration adalimumab biosimilar, and the passage and signing of the Inflation Reduction Act of 2022.

August brought with it 2 regulatory approvals for ophthalmology biosimilars; including an interchangeable one, an FDA approval for a high-concentration adalimumab biosimilar; and the passage and signing of the Inflation Reduction Act of 2022.

Inflation Reduction Act of 2022

During the month, the Inflation Reduction Act, or IRA, passed in the Senate and was signed into law by President Joe Biden. The IRA has drawn support and criticism from the biosimilar community because of some of the provisions that either did or did not make it into the final version.

First, the IRA gave CMS the power to negotiate drug prices directly with drug companies, which is thought to lower prices. Although some industry experts believe that this could be great for advancing biosimilar adoption and lowering costs, several biosimilar advocacy organizations have criticized the measure as harmful to biosimilars and potentially preventing competition, which is expected to have a greater impact on drug prices.

Additionally, before the Senate vote, the $35 out-of-pocket co-payment monthly cap on insulin products for patients with diabetes enrolled in private insurance plans was removed from the bill. The $35 cap was originally put in place for Medicare plans during the Trump administration; despite the Biden administration calling for the measure to extend to the private sector, the provision had to be removed after a point of order vote.

Ophthalmology Advances

The European Union and the United States approved a ranibizumab biosimilar, marking the second approval for an ophthalmology biosimilar in both markets.

Toward the end of the month, European Commission granted marketing authorization to Teva Pharmaceuticals’ Ranivisio for all 5 indications of the reference product (Lucentis), including age-related macular degeneration. Ranvisio was also the second ranibizumab biosimilar approved in the United Kingdom, under the name Ongavia.

Earlier, the US FDA approved Coherus Biosciences’ Cimerli (ranibizumab-eqrn). In addition to being the second ophthalmology biosimilar approved in the country, Cimerli is also the second ranibizumab biosimilar and the third interchangeable biosimilar to be approved in the United States.

Diversifying the Adalimumab Space

As the United States prepares for the 2023 influx of adalimumab biosimilars referencing Humira, 2 companies made moves to differentiate their biosimilars from the other 6 to 9 that are anticipated to launch next year.

Samsung Bioepis received FDA approval for its the high-concentration, citrate-free formulation of Hadlima (adalimumab-bwwd). The low-concentration formulation of Hadlima was approved in July 2019, and both formulations are expected to launch on the US market in July 2023.

Additionally, the FDA accepted an investigational new drug application seeking permission to test Celltrion Healthcare’s Yuflyma for interchangeability. Yuflyma is 1 of 3 adalimumab biosimilars that are under review with the FDA. Currently, only 1 adalimumab biosimilar has an interchangeability designation, and Celltrion is 1 of 5 seeking interchangeability for its adalimumab product.

In Other News

The European Commission granted marketing authorization to its seventh bevacizumab biosimilar referencing Avastin, Celltrion Healthcare’s Vegzelma (CT-P16). The biosimilar was approved for the treatment of several forms of cancer.

Lastly, the FDA accepted a biologics license application for Fresenius Kabi’s tocilizumab biosimilar candidate (MSB11456). The biosimilar would reference Actemra, a drug used to treat several autoimmune conditions. Fresenius Kabi said that it expects the FDA to approve the drug in 2023.

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