Prestige Biopharma's Avastin Biosimilar HD204 Nears Regulatory Approval and Commercialization

Prestige Biopharma's Avastin Biosimilar HD204 Nears Regulatory Approval and Commercialization

Prestige Biopharma (950210) is accelerating commercialization of its second biosimilar, targeting a market valued at approximately USD 7.3 billion (KRW 10 trillion). Upon successful launch, HD204is expected to serve as a key cash-generating asset alongside Tuznue, its Herceptin biosimilar that received European Commission (EC) marketing authorization in September 2024.

The company has secured topline data from the global Phase 3 clinical trial of HD204 (brand name: Vasforda®), a bevacizumab biosimilar of reference product Avastin. The trial was a randomized, double-blind, multicenter study conducted across 91 sites in 15 countries, enrolling 625 patients with advanced non-squamous non-small cell lung cancer (NSCLC), evaluating the efficacy and safety of HD204 against the reference product.

For the primary endpoint — objective response rate (ORR) at 18 weeks — HD204 achieved 48.7% versus 46.5% for reference Avastin, meeting pre-specified equivalence criteria and demonstrating clinical equivalence. Notably, treatment-related serious adverse events (SAEs) occurred in 5.2% of HD204 patients versus 8.3% in the reference arm, suggesting a favorable tolerability and safety profile alongside analytical similarity in the clinical setting.

Dr. Xavier Pivot of the Strasbourg Cancer Institute stated: "The clinical data fully met the prespecified equivalence margins, representing a successful demonstration of the clinical similarity of HD204."

The global bevacizumab market presents a compelling opportunity. According to Data Bridge Market Research, the market was valued at approximately USD 5.65 billion (KRW 8.6 trillion) in 2023 and is projected to grow at a CAGR of 9.8%, reaching USD 8.56 billion (KRW 13 trillion) by 2030. Biosimilar penetration already exceeds 60–70% in advanced markets such as Europe, rapidly displacing the originator product.

Prestige Biopharma targets a minimum 8% market share through HD204, which would represent a stable annual revenue stream of several hundred billion KRW. Its subsidiary Prestige Biologics provides an integrated in-house manufacturing capability, conferring a meaningful cost competitiveness advantage over peers.

Commercially, Prestige Biopharma has already secured a license-out and supply agreement with global pharmaceutical company Intas Group. In collaboration with Intas's subsidiary Accord Healthcare, the company is advancing regulatory submissions for the U.S. and European markets, with marketing authorization applications planned for submission to major regulatory agencies in the second half of this year.

The company's partnership track record further underpins investor confidence. Its earlier agreement with Teva — a global generics and biosimilars leader with annual revenues of KRW 23 trillion — for the European commercialization of Tuznue across 31 countries validated Prestige Biopharma's technical capabilities and is expected to accelerate HD204's global market entry.

Beyond biosimilars, Prestige Biopharma is reinforcing its innovative pipeline. PBP1510, a novel antibody therapeutic for pancreatic cancer, has received Orphan Drug Designation (ODD) from both the FDA and EMA and has been granted Fast Track status. Encouraging safety data from the ongoing Phase 1/2a trial continue to strengthen its commercialization prospects. The company is also advancing PBP1502, its Humira biosimilar, through Phase 1 clinical trials, pursuing a Fast-to-Market strategy centered on markets where Phase 3 requirements are streamlined under evolving global regulatory frameworks.

A company representative stated: "The clinical success of HD204, following Tuznue, demonstrates that we have established a fully competitive position in the global biosimilars market. We will leverage our technology, cost competitiveness, and strategic partnerships to pursue our target of KRW 30 trillion market capitalization by 2030."

Source: Eugene Hee Yoo, Edaily (https://www.edaily.co.kr/News/Read?newsId=03184886645386600&mediaCodeNo=257&OutLnkChk=Y)