Samsung Bioepis and Organon said Wednesday the preliminary review of the Supplemental Biologic License Application (sBLA) for interchangeability certification of Humira's biosimilar Hadlima (adalimumab) has been completed, and the review process has begun in earnest.

The two companies submitted their application to the U.S. FDA in August,

The sBLA submitted by Samsung Bioepis is based on the results of a follow-up clinical study (phase 4) conducted in patients with moderate to severe plaque psoriasis to confirm the pharmacokinetic similarity between the original drug and the higher concentration formulation of Hadlima.

Hadlima, which consists of a prefilled syringe and an autoinjector for self-injection, received U.S. marketing authorization for the low (50mg/mL) formulations in July 2019 and for the high (100mg/mL) formulations in August 2022. The company launched it in the U.S. on July 1, 2023, and Organon is marketing it.

"We applied for Hadlima’s interchangeability certification to expand the accessibility of our products to patients in the U.S. We will continue to strive to realize the value of biosimilars to contribute to the sustainability of the healthcare industry," said Jeong Byeong-in, leader of Samsung Bioepis’ RA Team.

Jon Martin, Head of US Biosimilars at Organon, said, "Beyond enabling pharmacy substitution, interchangeability clearance is important because it can increase physician confidence in prescribing biosimilars, and we look forward to making biosimilars more affordable and accessible to more patients."