Daewoong·Ildong late entries to the dapagliflozin market

Daewoong lists Forxilo tab 10 mg…Ildong has both monotherapy and combination therapy

Daewoong Pharmaceutical and Ildong Pharmaceutical have made late entries in the market for diabetes treatment containing 'dapagliflozin.' Although the door to the biosimilar market for dapagliflozin opened in April last year, these two companies did not join the market immediately.

 

It was presumed because of the contract binding with AstraZeneca, which owns the original product.

 

After resolving the binding contract and with Forxiga’s imminent withdrawal from the Korean market, two companies have likely entered the competition for the market.

 

According to industry sources on July 3rd, Daewoong Pharmaceutical’s 'Forxilo Tab 10 mg (dapagliflozin propanediol hydrate)' and Ildong Pharmaceutical’s two products of 'Daformet SR Tab (dapagliflozin bis L-proline/metformin hydrochloride)' became listed for reimbursement as of July 1st.

 

Forxilo Tab is a generic version of Forxiga (AstraZeneca), the original monotherapy, and Daformet SR Tab is a biosimilar referencing Xigduo XR tab (AstraZeneca) with a change to the salt form.

 

As the substance patent for dapagliflozin expired on April 7th, most pharmaceutical companies in South Korea have released either generics or biosimilars, such as salt-form-changed products.

 

However, Daewoong and Ildong were the exceptions.

 

At the time, Daewoong was in a joint agreement with AstraZeneca to sell Forxiga and Xigduo.

 

Ildong was preparing to launch reimbursed 'Qtern,' a combination therapy containing dapagliflozin plus saxagliptin.

 

Because of the joint-sales agreement with AstraZeneca for Qtern, Ildong could not release biosimilar referencing Forxiga and Xigduo.

 

Two companies entered the market for biosimilars as Forxiga was set to withdraw from South Korea after the canceling approval in April, and Xigduo’s joint-sales agreement was transferred to HK inno.N instead of Daewoong Pharmaceutical from January.

 

Daewoong Pharmaceutical listed 'Forxilo Tab 5 mg,' acquired through a transfer and acquisition deal, for reimbursement in April.

 

This month, Daewoong Pharmaceutical joined the competition in the market with reimbursed Forxilo Tab 10 mg, acquired through a transfer and acquisition deal.

 

Daewoong Pharmaceutical and Ildong Pharmaceutical join the market for biosimilars referencing Forxiga or Xigduo.

Daewoong Pharmaceutical has six years of experience selling the original Forxiga, from 2018 until last year.

 

Its generic drug is expected to settle in the market quickly.

 

Furthermore, Daewoong Pharmaceutical is also preparing to obtain reimbursement for its biosimilar, “Forxilomat SR tab (dapagliflozin·metformin hydrochloride).” The company is expected to launch biosimilars soon.

 

Ildong Pharmaceutical launched the reimbursable 'Dafor Tab 10 mg (dapagliflozin bis L-proline),' a biosimilar containing a salt form change, and secured reimbursement for its combination therapy.

 

The company is expected to pursue sales and marketing of its products.

 

As major pharmaceutical companies, Daewoong Pharmaceutical and Ildong Pharmaceutical, enter the market despite their one-year delay, the competition among biosimilars is expected to intensify.