News surrounding biosimilars referencing Humira (adalimumab) topped the list of biosimilar articles related to rheumatology in 2022, highlighting the excitement for these biosimilars to launch starting in early 2023.
News surrounding biosimilars referencing Humira (adalimumab) topped the list of biosimilar articles related to rheumatology in 2022, highlighting the excitement for these biosimilars to launch in the United States starting in early 2023.
5. FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar
The FDA approved the high-concentration version of Hadlima, 1 of 8 adalimumab biosimilars slated to launch on the US market next year. Hadlima was developed by Samsung Bioepis through a commercialization agreement with Organon, which will market the drug. The biosimilar is one of the only adalimumab biosimilars that will be offered in a high-concentration and a low-concentration formulation. Currently, the high-concentration version of the originator makes up about 80% of all adalimumab prescriptions.
4. Samsung Bioepis and Organon Seek to Enter the Market for High-Concentration Adalimumab
In January 2022, Samsung Bioepis and Organon, a spinoff of Merck, announced that they would collaborate to bring a high-concentration adalimumab biosimilar (Hadlima) to the US market. The product is expected to launch in July 2023 along with at least 6 others. The low-concentration version of Hadlima was approved in 2019. High-concentration adalimumab allows patients to receive fewer doses of adalimumab compared with a low-concentration version. The citrate-free aspect reduces pain for patients undergoing adalimumab therapy.
3. FDA Accepts BLAs Supporting Interchangeability From Alvotech, Pfizer for Biosimilars to Humira
The FDA accepted biologics license applications (BLAs) from Alvotech and Pfizer requesting for their respective adalimumab biosimilars to have interchangeability designations in the United States. The FDA set a goal decision date of December 2022 and both biosimilars (AVT02 and Abrilada) are expected to launch in July 2023. Pfizer’s Abrilada was approved in November 2019 and Alvotech’s AVT02 is being reviewed by the FDA.
2. AbbVie Settles ITC Case With Alvotech; Humira Biosimilar to Launch July 2023
AbbVie settled its outstanding lawsuits, including a case related to the International Trade Commission (ITC), with Alvotech, allowing Alvotech to launch its high-concentration, citrate-free adalimumab biosimilar in July 2023 once it’s approved. The settlement fully resolved all pending US disputes between the companies. In the ITC case, AbbVie alleged that Alvotech developed AVT02 through theft of trade secrets. The agreement removed any remaining litigation barriers keeping AVT02 from launching on the US market.
1. Canada Clears Alvotech Adalimumab Biosimilar for Launch
Health Canada approved Alvotech’s adalimumab biosimilar for launch on the Canadian market, where it will be marketed as Simlandi. The approval granted Alvotech permission to launch the product immediately. Humira generated over $700 million in 2020 for AbbVie. Simlandi is available as a 40-mg/0.4-mL and 80-mg/0.8-mL doses in prefilled syringes and self-injector pens. The news came shortly after Celltrion Healthcare received approval or its adalimumab biosimilar (Yuflyma) in January 2022.