Formycon and Bioeq Resubmit 351(k) Application

On August 5th, partners Formycon AG and Bioeq AG announced that they had completed its new biosimilar ranibizumab application to the Food and Drug Administration, with an eye toward a mid-2022 decision. The US marketer of the product, if approved, will be Coherus Biosciences.

The initial application was withdrawn in 2020 because of additional information required by the FDA, relating to the equipment that would be used in manufacture of the biosimilar. Based on the submission date, an FDA decision might be expected in the late second-quarter or early third quarter of 2022.

Currently, three manufacturers, including the Formycon/Bioeq/Coherus team, are in the late-stage development race for ranibizumab biosimilars. Samsung Bioepis is presently in the lead, with an FDA decision expected later this year. Xbrane Biopharm is planning to file its application in the fourth quarter of 2021. The reference product Lucentis® brought in approximately $1.7 billion in US revenue in 2020. As reported earlier this year, another manufacturer is seeking a sizable piece of these revenues, by applying for FDA approval (with an updated target date of the first quarter of 2022) of a manufactured (not compounded) ophthalmic form of bevacizumab. Ranibizumab is a fragment of the full bevacizumab molecule, and their efficacies (and that for aflibercept) are equivalent, according to clinical trials.  

In related biosimilar news

Coherus Biosciences currently is slotted as one of the last in the 2023 sequence of adalimumab biosimilar launches (December 15), based on their agreement with AbbVie. However, in the company’s latest earnings report, it stated, “The review of the CHS-1420 [biosimilar license application] is progressing with a target action date of December 2021. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.” We reached out to Coherus for comment but did not receive a reply by time of publication.

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