SBS Biz

By Kwang-Ho Lee

Hanmi Pharmaceutical said Rolvedon, the company’s novel drug that received an approval recently from the U.S. FDA, was included in the National Comprehensive Cancer Network’s (NCCN) treatment guidelines. Rolvedon is a medicine for neutropenia, an abnormally low concentration of neutrophils after chemotherapy. In 2015, Hanmi Pharmaceutical exported its technology for the drug to Spectrum Pharmaceuticals in the U.S. NCCN is an alliance of 32 cancer centers in the U.S. Its guidelines have been accepted virtually as standard remedies. Regardless of approvals from national institutions, doctors in the field have followed the guidelines, unless they are under unusual circumstances.

Guidelines describe Rolvedon as ‘third bullet'
Among multiple treatments for neutropenia, granulocyte-colony stimulating factor (G-CSF) is a method of treating the disease by emulating protein produced from bone marrow to make white blood cells. In the guidelines, Hanmi Pharmaceutical’s Rolvedon, which uses the method and which is known for its generic name, eflapegrastim-xnst, was described as the “third bullet.” This means that the method was accepted as the third treatment option along with two other options. Medical experts explained that the description does not necessarily mean that Rolvedon is an inferior option, compared to the first and the second bullets.

Looking at the three treatments, however, Rolvedon is practically regarded as an inferior option. The first and the second remedies are Amgen’s Neupogen and Neulasta, respectively. Neupogen’s generic name, filgrastim, is the first one, while Neulasta’s generic name, pegfilgrastim, is the second one. Both drugs prevent the decrease in neutrophils after chemotherapy. Neulasta is the modification of Neupogen for longer duration. NCCN labeled both medicines as “category 1” in its guidelines.

Unlike “bullet” which is irrelevant to superiority, “category” is meaningful. The definition of the category 1 is that “based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.” The levels of evidence and NCCN consensus become weaker, when it comes to category 2 and 3 treatments.

There is no category number for Rolvedon’s generic name. According to medical experts, this indicates that the drug is labeled the category 2, which means that based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. Among the three remedies in the guidelines, Rolvedon alone was given a lower category.

Need to prove Rolvedon’s competitiveness
Nevertheless, Rolvedon’s inclusion in the guidelines is still considered encouraging. Despite its lower category, it gained a foothold to enter the 4 trillion won ($3 billion) U.S. market, where Amgen’s two medicines occupy a combined 70 to 80 percent market share. If Hanmi Pharmaceutical secures at least 5 percent market share, it will be a great achievement for the Korean firm. Although Spectrum produces and sells Rolvedon in the U.S. market, Hanmi Pharmaceutical can receive royalties, as well as profits from exporting ingredients to Spectrum.

What is important is the competitiveness Rolvedon has, compared to Amgen’s products that dominate the market. In response, Hanmi Pharmaceutical said that “based on Hanmi’s independent platform technology, ‘Labscovery,’ the medicine spreads uniquely to bone marrow and affects continuously.” The company also explained that “as its efficacy is better than conventional products, its effect lasts three weeks after a single administration.” In addition, Hanmi Pharmaceutical emphasized that “in order to enhance the product’s competitiveness, we have swiftly conducted clinical trials on same-day administration.”


*This was translated from the article originally written in Korean. For more accurate information, please refer to the original version by using the link below. In case of discrepancies between the two versions, the Korean version shall prevail.
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