The domestic hair loss treatment market is experiencing a new wave, as pharmaceutical companies develop new formulations following generic drugs for male pattern baldness (androgenetic alopecia).
Industry executives pay keen attention to how they fare against original drugs long been proven effective and safe in the clinical field.
In May, Chong Kun Dang drew interest by submitting an IND (Investigational New Drug) application for a phase 3 clinical trial of CKD-843, a dutasteride-based injectable male pattern baldness treatment candidate, to the Ministry of Food and Drug Safety (MFDS).
The company plans to evaluate the efficacy and safety of CKD-843 in 273 subjects. The strategy is to overcome the inconvenience of daily oral dosing with a long-acting injectable with a three-month dosing interval.
Dutasteride, along with finasteride, is the leading 5-α-reductase inhibitor used to treat male pattern baldness and works by inhibiting 5-α-reductase, the enzyme that produces DHT (dihydrotestosterone), the cause of male pattern baldness. There are two types of 5-α reductase -- type 1 and type 2 -- and finasteride blocks type 2 while Avodart blocks type 1 and type 2 simultaneously.
Both components are currently off-patent, leading to a constant stream of generics. According to MFDS, 97 generics of dutasteride are in the Korean market, marked by a lower price than the original product.
On the other hand, the original product competes with the efficacy and safety confirmed through clinical trials. Avodart, the original dutasteride-based product, showed a 2.6 times higher increase in hair count than the placebo group at six months in phase 3 clinical trial in Korean patients with male pattern baldness and confirmed its long-term clinical utility in Korea through a three-year real-world evidence (RWE) study in Korean patients.
In addition, a phase 3 study evaluating the efficacy and safety of Avodart (dutasteride 0.5 mg), low-dose dutasteride, and finasteride 1 mg in 917 patients aged 20-50 years with male pattern baldness found that Avodart had the highest efficacy and safety profile similar to finasteride 1 mg.
“The hair loss treatment market is one of those with numerous generic drugs,” said Dr. Park Kyung-hoon, director of Kangdong Oaro Dermatology Clinic. “There is no difference in the chemical composition between the original and generic, so it is not that generic drugs are less effective. However, the difference is that generics are distributed between 80 and 125 percent of the bioavailability of the original drug set at 100.”
Park continued, “Because hair loss treatments are used on an ongoing basis for as long as you think you need hair, you have to be more cautious about the safety and efficacy of the treatment. The original drug has the advantage that its effectiveness has been confirmed in multiple clinical trials and used in clinical practice for a long time.”
“Dutasteride is the only oral treatment for male pattern baldness licensed in Korea with an action mechanism that inhibits both 5-α reductase enzymes. Avodart, the original dutasteride, provides rapid hair loss improvement, with global clinical trials showing significantly greater improvement than finasteride 1 mg at three months of treatment,” he added.
“We recommend that men start treatment as soon as possible when symptoms of hair loss occur and continue treatment for as long as they feel they need it, as long as they are treated with a treatment effective and safe,” Park advised.