In an effort to more closely match the options available with AbbVie’s reference product, partners Samsung Bioepis and Organon sent the US Food and Drug Administration a supplemental 351(k) application for a citrate-free, 100-mg/mL form of Hadlima™. The FDA accepted the application, according to the January 5th press release.
Hadlima, which was originally approved in July 2019, is a low-concentration (50 mg/mL) biosimilar of adalimumab and is not citrate-free. The majority of current Humira® use is of the citrate-free form, which is claimed to reduce skin irritation and pain at the injection site.
By our count, 7 of the 10 adalimumab biosimilars either approved or under FDA review may be available as citrate-free formulations (Table) in 2023. Four of these manufacturers are either approved in the higher-concentration medication or have an application under active review.
The supplemental application for Hadlima was based on a phase 1 study comparing the two dosage formulations of the biosimilar in 188 healthy volunteers. The pharmacokinetics, safety profile, and immunogenicity results indicated no material differences between the two agents. Note that the FDA did not require further comparison of the high-concentration biosimilar against Humira, evidently because the agency considers the approved biosimilar as the appropriate comparator.
Organon is a spin-off of Merck, which originally held the commercialization agreement with Samsung Bioepis. Organon has taken over all biosimilar-related activities from the parent company.
Samsung will launch Hadlima no earlier than July 2023, according to the company.