Betmiga generics’ market share rises to 49%...

Sales of Hanmi and CKD's mirabegron generics rise sharply

Mirabek KRW 3.8 billion, Selebeta KRW 1.7 billion.... original drug’s sales drop to half in 3 years

Jeil’s Beova and Dong-A’s DA-8010 to soon be released...remains a variable in Korea’s OAD market

Miragegron original Betmiga (left) and its generic versions Mirabek and Selebeta (right)

Generic versions of mirabegron have increased their influence in Korea’s overactive bladder market.

 

The overall market share of the generic products in Q1 was 49%, chasing sales of the original drug, ‘Betmiga,’ right under the nose.

 

In particular, sales of Hanmi Pharmaceuticals ‘Mirabek’ and Chong Kun Dang’s ‘Selebeta’ have shown rapid growth.

 

On the other hand, the prescription performance of the original product, Astellas Betmiga, dropped to less than half in 3 years after the release of its generics.

 

Betmiga’s generics increase market share to 49%...Sales of original continue to decline According to the market research institution UBSIT on the 6th, the OAB market for the mirabegron ingredient had been KRW 15.6 billion in Q1, which is a 21% increase from the KRW 12.9 billion in Q1 2022.

 

The market expansion was led by mirabegron generics.

 

The overall prescription performance of the 22 Betmiga generics currently released in Korea reached KRW 7.7 billion, which is a 64% increase from the KRW 4.7 billion in Q1 last year.

 

On the other hand, the decline in the prescription of the original mirabegron drug, Betmiga, is evident.

 

In Q1, its prescriptions had fallen 3% from KRW 8.2 billion in Q1 2022 to KRW 8 billion this year.

 

The amount is less than half of what it had made in Q1 2020, immediately before the release of its generics.

 

Astellas had been delaying the execution of the price cut disposition on Betmiga that follows the release of generics by filing administrative suits and suspension of disposition execution requests, but had lost the final suit early last year and received price cuts.

 

The increasing influence of its generics aggravated the decline in the prescription performance of the original drug.

 

At this pace, sales of generics will exceed the original’s and take over the majority of market share in Q2 at the earliest.

 

Mirabek and Selebeta’s sales grow rapidly...

 

Domestic pharmaceutical companies’ new OAD drugs remain a variable in the market By product, sales of Hanmi Pharmaceuticals ‘Mirabek’ and Chong Kun Dang’s ‘Selebeta’ have shown rapid growth.

 

In the case of Mirabek, its sales had increased 18% from KRW 3.2 billion in Q1 last year to KRW 3.8 billion in Q1 this year.

 

In the same period, Selebeta’s sales have also risen from KRW 1.3 billion to KRW 1.7 billion.

 

Sales of generics produced by the other 20 companies have raised less than KRW 0.5 billion in quarterly sales.

 

Hanmi Pharmaceutical and Chong Kun Dang released their generics one after another after winning the patent dispute with Astellas in June 2020.

 

In February last year, 20 additional companies released their generics after the generic exclusivity period expired for the two companies.

 

The quarterly prescriptions of 20 companies that released products after the generic exclusivity period were all less than KRW 0.5 billion, but their growth rate is also quite steep.

 

Therefore, the new OAD drugs released by domestic pharmaceutical companies are expected to act as the variable in this market.

 

Jeil Pharmaceutical

Jeil Pharmaceutical received approval for its new OAD drug, ‘Beova (vibegron)', in November last year.

 

Jeil Pharm plans to supply this product, which was developed by Kyorin Pharmaceutical in Japan, within the year.

 

Recently, it held a symposium for doctors, indicating its imminent entry into the market.

 

By selectively acting on β3-adrenoceptor agonists, Beova relaxes the bladder and enhances urine collection.

 

Its mechanism of action is similar to mirabegron, but Beova is known to have a higher response rate to β3 receptors and a low risk of cardiovascular side effects Dong-A ST is also in the final stages of developing a new OAD treatment.

 

Dong-A ST has been conducting a Phase III trial in Korea for its OAD drug candidate 'DA-8010' since January last year.

 

This drug is an antimuscarinic drug developed by Donga.

 

Antimuscarinic drugs act primarily in the urine storage phase when the parasympathetic nerve is not activated, suppressing involuntary contraction of the bladder, reducing urinary urgency, and increasing bladder volume.

 

In terms of mechanism, it is similar to another overactive bladder treatment, 'Veshcare (Solifenacin)'.

 

DA-8010 is a new antimuscarinic being developed by Dong-A ST.

 

Antimuscarinics inhibit involuntary contraction of the bladder and reduce urinary urgency to increase bladder capacity by primarily acting in the urinary storage phase where parasympathetic nerves are not activated.

 

its mechanism of action is similar to that of ‘VESIcare (solifenacin),’ another OAD treatment.