Companies in KOR and abroad compete in Eylea biosimilar mkt

Sam Chun Dang Pharm applies for approval of its Eylea biosimilar on Nov 30th

In addition to multinational pharmaceutical companies like Amgen and Sandoz, Samsung Bioepis and Celltrion also make bid into the market

Intense challenges are being made against Bayer's Eylea, the current leader in the macular degeneration market.

 

Not only domestic biosimilar companies like Celltrion and Samsung Bioepis but also traditional pharmaceutical companies such as Sam Chun Dang Pharm have thrown down the gauntlet.

 

Bayer and Regeneron, the original developers of Eylea, thus face fierce market competition not only with biosimilar developers but also with Roche's next-generation macular degeneration treatment, Vabysmo.

 

According to industry sources on the 3rd, among domestic companies, Sam Chun Dang Pharm, Celltrion, Samsung Bioepis, and Alteogen are currently developing Eylea (aflibercept) biosimilars.

 

All four companies have set their sights on the global market, preparing to receive approvals in the U.S.

 

and Europe in addition to the Korean market.

 

In the U.S., Celltrion, Amgen, and Sandoz are close to commercializing their biosimilars in the U.S.

 

These companies have now completed global Phase III clinical trials and applied for marketing authorization in the U.S.

 

and Europe.

 

Eylea’s U.S.

 

new drug exclusivity expires next May, and its European substance patent expires in November 2025.

 

In Korea, Sam Chung Dang Pharm is nearing approval.

 

The company applied for the marketing authorization of its Eylea biosimilar candidate ‘SCD411’ in two formulations - vial and prefilled syringe formulation – in Korea last month.

 

Sam Chung Dang Pharm is the first company to apply for the approval of a prefilled syringe formulation of Eylea.

 

The application was filed based on SCD411’s Phase III trial results.

 

The trial, which had been conducted on 576 patients, demonstrated SCD411’s bioequivalence to Eylea.

 

Based on the results, Sam Chung Dang Pharm is also preparing to apply for marketing approval of SCD411 in the United States and Europe as well.

 

Eylea to inevitably compete with biosimilars and Vabysmo

Pharmaceutical and bio companies in Korea and overseas have jumped into developing biosimilars due to the high marketability of Eylea.

 

Eylea’s global sales were approximately USD 1.4 billion (KRW 1.9 trillion) in Q1 this year and USD 1.5 billion (KRW 2.373 trillion) in Q2 this year.

 

Eylea had posted the highest sales in the domestic macular degeneration market.

 

According to the pharmaceutical market research institution IQVIA, Eylea’s sales, which had been around KRW 46.8 billion in 2019, exceeded KRW 60 billion in 2020.

 

Sales continued to grow, and Eylea posted KRW 80.4 billion in sales last year.

 

However, sales generated by Eylea’s competitors last year, Novartis’ Lucentis (ranibizumab) and Beovu (brolucizumab) were only KRW 29.4 and KRW 14.5 billion, respectively.

 

In addition to the challenges made by the biosimilar developers, Bayer’s Eylea is starting competition in earnest with Roche's macular degeneration drug Vabysmo (faricimab).

 

Unlike existing VEGF inhibitors like Lucentis, and Eylea, the drug’s dual mechanism of action allows for it to also block the angiopoietin-2 (Ang-2) pathway to inhibit neovascularization.

 

In particular, in clinical trials, Vabysmo improved visual acuity at a level non-inferior to that of Eylea, which is administered at 8-week intervals, when administered at intervals of up to 16 weeks.

 

Vabysmo was granted reimbursement and released in earnest in October last month.

 

Roche is also known to be planning to introduce a prefilled syringe formulation of Vabysmo next year.