Biosimilar makers continue to supplement their biosimilars’ profile in an effort to produce the most attractive offering to payers. In the latest news, Sandoz announced that it filed a supplemental application with the Food and Drug Administration (FDA) to gain approval for a high concentration and citrate-free formula.
Sandoz’s adalimumab biosimilar Hyrimoz® was initially approved as a 50-mg/mL formulation of the reference product Humira®. The supplemental application is supported by the results of a phase 1 bridging study, according to Sandoz, which demonstrated similar pharmacokinetics, safety, and immunogenicity between the two formulations. Hyrimoz has been marketed in Europe since 2018 in the low-concentration form. Sandoz has also submitted an application to the European Medicines Agency to review this newest form.
AbbVie introduced the 100-mg/mL dose in 2016 and its citrate-free version in 2018 and has converted the majority of Humira users to this latest formulation. Biosimilar makers are seeking to match this offering, as payers and providers may view it as causing the least disruption to the patient.
Adalimumab Biosimilars Launching in 2023
|Amgen||Amjevita*||50-mg/mL dose concentration, CF, 29G needle (interchangeable and 100-mg/mL formulation possible after launch)|
|Samsung Bioepis/Merck||Hadlima*||50-mg/mL, 29G needle; (100-mg/mL, CF approval applied for)|
|Boehringer Ingelheim||Cytelzo*||50-mg/mL, CF, interchangeable|
|Mylan/Fujifilm Kyowa Kirin Biologics||Hulio*||50-mg/mL, CF, 29G needle|
|Sandoz||Hyrimoz*||50-mg/mL (100 mg/mL, CF approval applied for)|
|Pfizer||Abrilada*||50-mg/mL, CF, 29G needle, (interchangeability approval applied for)|
|Celltrion||CT-P17||100 mg/mL, CF, 29G needle|
|Alvotech/Teva||AVT02||100 mg/mL, CF interchangeable approval applied for|
CF = To be launched in a citrate-free formulation, similar to the reference product.
*Received FDA approval as of February 1, 2022. Chart Updated 7/21/2022.
We expect this jockeying for position to continue fervently in the next 18 months. We last posted the overview of the adalimumab competitors in January. There have been some changes since that time, which we have reported on separately. Here is the updated chart, with updates marked in bold. We’ll add updates to this table as appropriate, right through the mid-year 2023 launches of these biosimilars.
(revised July 22, 2022)