Product Approvals and Launches

The US gains 2 more adalimumab biosimilars on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

Celltrion USA launched its fifth biosimilar in the United States, Yuflyma (adalimumab-aaty), a biosimilar referencing Humira that is also 1 of 8 adalimumab products expected to launch in July.

After years of waiting and legal battles, the first of the 8 adalimumab biosimilars expected to launch in July 2023 have entered the market.

Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab).

Amneal Pharmaceuticals has announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).

The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.

Amgen’s Amjevita (adalimumab-atto) has officially entered the US market, making it the first of potentially 10 biosimilars referencing Humira to launch in 2023.