Brenzys, Samsung Bioepis Co.’ biosimilar drug for rheumatoid arthritis (RA), has passed therapeutic evaluation at Hanyang University Medical Center’s RA Hospital, the best known health facility for RA treatment in South Korea. Preion may be possible from late March if customary contract procedures end smoothly.

According to sources on Wednesday, Hanyang University Medical Center gave the green light for purchasing of Brenzys developed by Samsung Bioepis and marketed by MSD Korea. The hospital launched Korea’s first RA-focused treatment center and its RA patients reach 90,000 per year.

Brenzys is Samsung Group’s headline biosimilar product approved by Korea`s Ministry of Food and Drug Safety and the European Medicines Agency last year. Marketing began last September in Korea. MSD, the world’s No. 3 healthcare company, was aggressive in marketing the drug in Korea but had to overcome challenges due to doctors’ prejudice against copied drugs.

The hospital’s acceptance and preion will be a tipping point to further demonstrate the efficacy and safety of Brenzys. The RA center has 19 professor-level physicians much higher that two to three clinicians or specialists at other university hospitals. That’s why Hanyang University Medical Center is often called the quaternary health facility in RA. Treatment with this drug in as many as 90,000 patients will bring a vast amount of clinical data that will contribute to silencing any safety controversy.

Prejudice against the equivalence of Brenzys and the drug’s weakness in price, which has little difference from its reference drug, can also be addressed with the successful evaluation result. Pfizer, which sells the original drug in Korea, cut its price after the biosimilar was launched, narrowing the actual price difference to just 5 percent.

But it can make a difference for patients who should take the RA drug for the rest of their life. Medical expenses burdened by RA patients amount to 2.18 trillion won ($1.86 billion) a year, or nearly 8 million won per patient. Annual sales of Enbrel, the original RA drug, hit 9.5 trillion won worldwide.

Samsung Bioepis already demonstrated Brenzys is equivalent to the reference product in efficacy through several clinical trials.

Enbrel is given to patients with severe rheumatoid arthritis who failed to respond to existing synthetic drugs. Samsung Bioepis presented results from a 52-week Phase III equivalence study of Brenzys involving 500 RA patients during the American College of Rheumatology (ACR) scientific session late last year.

“If Brenzys is prescribed to many patients instead of Enbrel at general and university hospitals like Hanyang University Medical Center, the prejudice against safety of biosimilar products will disappear naturally,” said a market expert.

By Lee Dong-in

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