A Profile on Lesser-Known Player in the Biosimilar Space: Prestige Biopharma

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight an interesting company based in Singapore.

Founded in 2015, Prestige Biopharma has production facilities in South Korea and a research center in Cambridge, Massachusetts. Lisa Park, one of the founders, is listed as its CEO (interestingly, its website does not disclose the leadership team). The company is focused on biosimilar development and a couple of innovative products. Prestige has also been involved with COVID-19 vaccine production over the last year or so.

Why you may be hearing more about this company: Prestige has one product approaching the registration phase: a trastuzumab biosimilar (HD201) that may be submitted for FDA approval by Q3 2022. HD201 has already been submitted to the EMA for review, after completion of its phase 3 trial last month. In addition, its bevacizumab biosimilar HD204 is currently in late-stage clinical study (to be completed in December 2022).  An adalimumab biosimilar in entering phase 1 trial.

However, Prestige’s website lists nine other biosimilars in preclinical stages, covering products like aflibercept, denosumab, eculizumab, nivolumab, pembrolizumab, pertuzumab, and ipilimumab. Interestingly, they are also engaged in preclinical research for a natalizumab biosimilar (reference drug Tysabri®), which is also being a target of Sandoz. The one difference is that Sandoz is seeking approval for the multiple sclerosis indication (which accounts for about 90% of Tysabri® utilization), and Prestige notes that the Crohn’s disease indication is its focus.

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