Generic for Teribone was approved & the competition began

BMIKOREA, Teria acquired item approval on the 28th

Dong-A ST

As a treatment for osteoporosis, generics have begun to be released in the latest bone formation promoting agents.

 

Following Lilly's Forsteo, Dong-A ST's Teribone was also a generic version.

 

The MFDS approved Terrosa 56.5μg (Teriparatide acetate) from BMIKOREA on the 28th.

 

Terrosa is a generic of Teribone subcutaneous injection 56.5 μg and the same ingredient (Teriparatide acetate), which was approved by Dong-A ST in November 2015.

 

This is the first time Generic for Teribone has been licensed.

 

Teribone is a partially synthesized formulation of parathyroid hormone involved in bone formation, and is a product introduced in Korea by Dong-A ST from Asahi Kasei Pharma in Japan.

 

In a clinical trial in Japan, it showed a fracture inhibitory effect that reduced the incidence of vertebral fractures to 78.6% compared to the placebo group.

 

In particular, in Korea, it is treated like IMD because of improved ease of administration than Lilly's Forsteo (Teriparatide), which was licensed in 2002.

 

Forsteo should be injected subcutaneously once a day, whereas Teribone can be injected once a month.

 

In December 2016 by Forsteo and January 2017 by Teribone, benefits were recognized for patients who were ineffective or unable to use existing bone resorption inhibitors.

 

Therefore, it has been in the domestic market in less than four years.

 

Generic for Forsteo was released for the first time and was in competition.

 

In October of last year, Forsteo's biosimilar'Terrosa cartridge' by Daewon was approved.

 

This product was developed by Richter-Helm, a Hungarian-German pharmaceutical joint venture, and was given a re-examination for four years (until October 28, 2023) in recognition of its equivalence with the original.

 

With BMIKOREA's approval of generic for Teribone this time, the number of promoting bone formation drugs of Teriparatide increased to four.

 

Forsteo and Teribone's IQVIA sales last year were 21.7 billion won and 2.9 billion won, respectively.

 

The gap between Forsteo and Teribone is widening.

 

If generics such as BMIKOREA's Teria are sold in earnest following Daewon's Terrosa, it is believed that it will affect the market structure.

 

Terrosa was released last May.