Soliris to Ultomiris...generation shift picks up speed

for ultra-high-priced orphan drugs

Quarterly sales of PNH treatment Soliris drop sharply from ₩11.4 billion to ₩2.8 billion in one year

Follow-on drug Ultomiris raises ₩9.6 billion in sales in Q1…replaces Soliris

Whether Handok’s strategy of keeping Soliris’ biosimilars in check before their release will work receive attention

The generation shift between Handok’s paroxysmal nocturnal hemoglobinuria treatments Soliris (eculizumab) and Ultomiris (ravulizumab) is gaining speed.

 

With Ultomiris quickly replacing Soliris, Handok’s strategy of checking the release of Soliris’s biosimilars is also being considered a success.

 

◆Sales of Soliris drop 75%… replaced by its follow-on Ultomiris According to the market research institution IQVIA on the 24th, Soliris’s sales in Q1 this year recorded ₩2.8 billion.

 

This is a 76% drop from the ₩11.4 billion it had made in Q1 2021.

 

However, the rise in Ultromiris’s sales more than made up for the reduced sales of Soliris.

 

Ultromiris raised ₩9.6 billion in sales in Q1 this year, exceeding the reduction in sales seen with Soliris (₩8.6 billion).

 

Quarterly sales of Soliris and Ultomiris (Unit: 100 million won, IQVIA)

Ultromiris is Soliris’s follow-on drug that has reduced the number of required administrations.

 

Ultomiris can be administered every 8 weeks as maintenance therapy after the initial dose.

 

However, Soliris needs to be administered biweekly.

 

The drug was developed by Alexion (now AstraZeneca) and Handok is in charge of its domestic sales.

 

Ultromiris started generating sales in Q3 after the drug was listed for reimbursement in June last year.

 

Ultromiris had been showing high performance since its reimbursement, generating ₩8.9 billion in Q3, then ₩10.7 billion in Q4 last year.

 

Ultomiris drew much attention in the prescription field since its reimbursement listing.

 

According to the Health Insurance Review and Assessment Service, Ultomiris received 47 applications for prior approval in the first month of June 2021 alone.

 

Only 9 new applications for prior approval were filed for Soliris in the same period.

 

Soliris and Ultomiris, which were both listed as ultra-high-priced drugs, require prior approval on their eligibility for insurance reimbursement.

 

The institutions that apply for prior approvals must administer the drug within 60 days of receiving HIRA’s deliberation results.

 

Ultomiris’s prior approval applications amounted to 67 in the second half of last year.

 

New applications for Soliris’s prior approval in the same period were only 16.

 

Among these, only 1 new application was filed for the prior approval of Soliris to treat PNH, the indication that is also held by Ultomiris.

 

The other 15 new applications were filed for the treatment of atypical Hemolytic Uremic Syndrome, an indication not covered by Ultomiris.

 

◆Handok chose ‘speed’ over ‘price’ to contain the rise of its biosimilars

Soliris(left), Ultomiris (right)

Handok’s reimbursement listing strategy is also receiving attention with the speedy generation shift between Soliris and Ultomiris.

 

Handok received marketing authorization for Ultomiris in May 2020.

 

In the process of receiving reimbursement approval, the drug’s insurance price was set lower than the weighted average of Soliris (₩5,598,492), at ₩5,132,364 per vial.

 

At the time, the interpretation that Handok focused on ‘speed’ rather than ‘price’ had prevailed.

 

Ultimately, Handok succeeded in listing Ultomiris for reimbursement in only 10 months since it applied for insurance benefits in August 2020 as planned.

 

It is interpreted that Handok made such a decision with Soliris’s biosimilars in mind.

 

In Korea, Samsung Bioepis and Isu Abixs are currently developing Soliris biosimilars.

 

Handok's strategy was to quickly register Ultomiris before the biosimilars in development enter the market, and drive prompt switching to the follow-on drug.

 

From this year’s Q1 results, it is evaluated that Handok's fast registration strategy to contain biosimilars was successful to some extent with the rapid switching of Soliris to Ultomiris.

 

PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system.

 

Without treatment, 4 out of 10 patients die within 5 years after diagnosis.

 

The survival rate of those who are treated with Soliris or Ultomiris has been found to improve to 95.5%.

 

In Korea, around 200 patients suffer from PNH.