Higher dosage Eylea expected to strike back at biosimilars

Eylea Inj 8 mg, with extended treatment interval by more than twice, will be listed for reimbursement

Economical than the existing original drug 2mg…new drug costs KRW 795,000

The competition in the market for the macular degeneration drug Eylea has recently intensified with Samsung Bioepis and Celltrion, which have recently launched biosimilars.

 

The original developer is set to strike back against the competitors.

 

Bayer will release Eylea Inj 8 mg (aflibercept), with an extended treatment interval, into the market next month at a relatively cheaper price.

 

According to the industry on September 25th, Eylea Inj 8 mg will be listed for reimbursement next month at a price lower than the evaluation price, KRW 795,000.

 

Eylea Inj 8 mg provides a long-lasting, effective dosage within the eye at a four times higher dosage than the previous 2 mg.

 

It extends the treatment interval while reducing the number of injections.

 

Eylea Inj 8 mg is injected once monthly for an initial 3 months.

 

Then, based on visual and anatomical test outcomes, a treatment interval can be extened up to 16 weeks at the physician's judgement.

 

After the initial extension of the treatment interval, it can be extended up to 20 weeks with the Treat-and-Extend(T&E) therapy.

 

This approach allows flexibility in adjusting the treatment interval depending on the patient's condition while maintaining stable vision and anatomical test outcomes.

 

The original and biosimilars currently sold in the market are at a 2 mg dosage.

 

For neovascular age-related macular degeneration (nAMD) treatment, the drugs are injected once monthly for an initial 3 months, followed by a once every 2 months treatment regimen.

 

Using the new 8 mg will extend the treatment interval more than twice, from once every 2 months to once every 4 months.

 

The PULSAR study secured non-inferiority results of the new product by showing that patients treated with Eylea 8 mg at a 12-week interval had the best corrected visual acuity (BCVA) of 6.7 letters on average from the baseline at 48 weeks, those at a 16-week interval had BCVA of 6.2 letters, and those at an 8-week interval had the BCVA of 7.6 letters.

 

However, the drug price is not more than double the original price.

 

Due to the biosimilar release, the current ceiling price for Eylea Inj·Prefilled Syringe is KRW 496,118, a 30% reduction from the highest price.

 

The newly listing Eylea Inj 8 mg costs KRW 795,000.

 

Despite extending the treatment interval more than twice, the price has not doubled because Bayer has set the price lower than the evaluated price.

 

However, the price is double that of biosimilars.

 

Samsung Bioepis' Afilivu Inj 40 mg/ml costs KRW 350,000, and Celltrion's Eydenzelt Inj costs KRW 330,000.

 

Although the price of biosimilars is low, newly diagnosed patients are likely to choose the high-dose original drugs, which require fewer injections due to the extended treatment interval.

 

Hence, Eylea Inj 8 mg will likely be a direct competitor to biosimilars.

 

Eylea is a blockbuster product, recording KRW 96.8 billion in sales last year, based on IQVIA.

 

Due to its marketability, Samsung Bioepis and Celltrion, which have released their products in May and September, respectively, are trying to seize the market by partnering with pharmacists who are specialists in ophthalmology.

 

Industry personnel said, "Patients who are benefiting from the existing Eylea 2 mg are less likely to switch products.

 

However, new patients are likely to choose from biosimilars, with lower cost, and high-dosage original drug, with fewer injections," adding, "An intense competition among overseas original developer and Korean biosimilar developers is expected."