Prestige Biopharma Receives Approval for Phase 1 Trial of Humira Biosimilar in Hungary

“Plan to Conduct Phase 1 and Phase 3 Trials Concurrently Upon Safety Confirmation”

Prestige Biopharma (950210), a biopharmaceutical company specializing in antibody therapeutics, announced on the 15th that it has received approval in Hungary for a global Phase 1 clinical trial of its Humira biosimilar, PBP1502.

Following the ongoing Phase 1 trial in Spain initiated last year, the company has secured an additional clinical site in Hungary, further accelerating its development efforts. The Phase 1 trial in Hungary will be conducted at three clinical institutions.

The Phase 1 study will involve approximately 324 participants and will evaluate pharmacokinetics, immunogenicity, and safety by randomly administering PBP1502 alongside reference products marketed in the United States and Europe. Upon confirming safety through interim data, the company plans to apply for a Phase 3 trial involving approximately 460 patients with psoriasis. Following confirmation of comparable efficacy and safety to the reference product, Prestige Biopharma aims to pursue rapid regulatory approvals in both the United States and Europe.

PBP1502, a biosimilar to Humira, is manufactured using a patented “Non-Protein A purification method for adalimumab,” enabling high antibody expression and high-concentration formulation with superior quality. The product is expected to have strong price competitiveness through a full value chain production system operated by its affiliate, Prestige Biologics.

Prestige Biopharma noted that the global market for Humira reached USD 20.9 billion (approximately KRW 27 trillion) last year, and with recent patent expirations in the U.S., the biosimilar market is expected to expand significantly.

A company official stated, “PBP1502 is one of our key pipeline assets. To accelerate entry into European clinical trials, we have carefully designed the protocol over the past several months based on previous clinical experience and recent clinical trends.” The official added, “This year will be a significant growth milestone for our four major pipelines, including PBP1502, as well as HD201, a Herceptin biosimilar approaching regulatory submission in the U.S. and Europe; HD204, an Avastin biosimilar currently in Phase 3; and PBP1510, our antibody therapeutic for pancreatic cancer.”

Reference: Edaily (https://www.edaily.co.kr/News/Read?newsId=02243526635510848&mediaCodeNo=257)