Galvusmet generics released in all dosage forms in KOR

Starts 2nd round of competition

Hanmi and KyungBo Pharma were the only companies that offered all 3 dosage forms

4 companies including Genuone Sciences list their Galvusmet generics

Novartis Korea

The second round of competitions is now on with the entry of Galvusmet generics.

 

If the first round was held between generics before and after Galvusmet’s substance patent expiry, the second round this time expected this time is set to start with the release of Galvusmet generics that come in all dosage forms.

 

According to the industry on the 26th, Daewoong Bio, Mothers Pharmaceutical, and Korea Hutex Pharmaceutical, led by the contracted CDMO Genuone Science, will launch all dosage forms of Galvusmet generics.

 

Galvusmet is a combination of the DPP-4 inhibitor vildagliptin and metformin hydrochloride.

 

Novartis Korea received approval for the drugs in 2008 in Korea.

 

It had been offered in three doses, Galvusmet Tab 50/500mg, Galvusmet Tab 50/850mg, and Galvusmet Tab 50/1000mg.

 

Five companies (United Pharma Korea, Shinpoong, Ahn-gook, Ahn-gook New Pharm, Samjin) had previously released a 50/500mg dosage of the same-ingredient generic.

 

Only Hanmi Pharmaceutical’s Vildaglmet Tab and KyungBo Pharma’s Vildamet Tab offered all the dosage forms offered by Galvusmet, and were self-modified drugs.

 

So this is the first time 50/850mg, and 50/1000mg same-ingredient generics are being released in Korea.

 

Last year, Galvus (including single and combination drugs) posted outpatient prescription sales of KRW 14.5 billion (UBIST data).

 

Among the amount, the original Galvus series posted KRW 32.4 billion in prescriptions, down 30% YoY due to the release of generics.

 

Among the latecomers, Hanmi’s Vildagle series showed the highest performance of KRW 3.9 billion.

 

The analysis is that the company succeeded in preoccupying the market by launching a variety of dosage options.

 

The competition is expected to intensify further with the release of the generic versions in all dosages.

 

In particular, these Galvus generics were released after the enforcement of patent avoidance and bioequivalence t sharing regulations 1 (consignee) + 3 (consignor) and therefore will have fewer competitors than Forxiga or Januvia, which will work in favor of the generic companies in terms of sales and marketing.

 

Also, the fact that the market size for the combination drug Galvusmet is 5 times larger than that of its single-agent drug Galvus is also a factor that the generic companies are looking forward to.

 

Last year, Galvus recorded outpatient prescriptions of KRW 5.4 billion, while Galvusmet recorded KRW 26.9 billion.