FDA approves Samsung and Biocon’s Eylea biosimilars

Sparking competition in the market

Samsung Bioepis’s Opuviz and Biocon Biologics's Yesafili receives approval in the US

Both products were approved with interchangeability designations…can be substituted for the reference product at the pharmacy level without doctors’ prescriptions

Competition in the AMD market intensifies with the introduction of Eylea biosimilars and Vabysmo

Samsung Bioepis’s Opuviz became the first Eylea biosimilar to be approved in the US.

 

In particular, due to its interchangeability designation, Opuviz can be administered interchangeably with Eylea, increasing its chances of gaining an advantage in the market over its competitors.

 

According to KoreaBIO on the 21st, the US FDA approved Samsung Bioepis’s Opuviz and the Indian Biocon Biologics's Yesafili as interchangeable biosimilars that can substitute the original macular degeneration treatment Eylea.

 

The approval will allow pharmacies in the US to make substitutions of Eylea at the pharmacy level without an additional physician’s prescription.

 

The FDA began designating interchangeable biosimilars in July 2021.

 

This was the FDA's recognition that a biosimilar can be prescribed to any patient and produce the same clinical outcomes as the original drug.

 

Unlike generic drugs, which must demonstrate bioequivalence, biosimilars demonstrate biosimilarity at the time of approval.

 

This is because the cells used in manufacturing, the manufacturing process, among others cannot be the same as the original drug.

 

As a result, ensuring interchangeability is considered a key to expanding sales.

 

In fact, in the Humira biosimilar market, Samsung Bioepis and Celltrion, in addition to Boehringer Ingelheim and Pfizer, are conducting Phase IV clinical trials to confirm the possibility of its biosimilar’s interchangeability.

 

#SBBiosimilars and new drugs heat up market competition#EB #I2The competition in the macular degeneration treatment market is expected to intensify with the entry of Eylea biosimilars.

 

Currently, not only Samsung Bioepis and Biocon, but also later entrants such as Sam Chun Dang Pharm and Celltrion have jumped into biosimilar development.

 

Eylea is a vascular endothelial growth factor-A (VEGF-A) inhibitor for macular degeneration that was developed by Bayer and Regeneron.

 

The drug, which remains a strong market leader since its approval, generated global sales of USD 9.148 billion (KRW 12.58 trillion) last year.

 

It works by inhibiting vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth in the eye.

 

By blocking VEGF, Eylea can help slow or reduce retinal damage and preserve vision.

 

Eylea has an advantage in terms of dosing interval over its competitors.

 

Eylea can be dosed every 2 months compared to Novartis' Lucentis (once a month), demonstrating its longer duration of effect.

 

Eylea was also shown to be superior to Lucentis in diabetic macular degeneration, which results in a severe form of vision loss.

 

In preparation for the inflow of Eylea biosimilars, Bayer and Regeneron developed a high-dose version of Eylea to defend the market.

 

Their plan was to launch a higher-dose formulation and further increase dosing intervals.

 

Bayer and Regeneron are aiming to get approval for Eylea high-dose for all of the indications they have secured, including diabetic macular edema, age-related macular degeneration, and retinal vein occlusion.

 

The variable is Roche’s Vabysmo, which emerged as a formidable competitor to Eylea.

 

Vabysmo is a macular degeneration treatment that was developed by Roche.

 

The drug not only inhibits VEGF but also blocks the angiopoietin-2 (Ang-2) pathway to inhibit neovascularization.

 

Blocking both pathways independently has been shown to be more effective than blocking VEGF alone in reducing inflammation, leakage, and abnormal blood vessel growth.

 

Vabysmo improved visual acuity at a level non-inferior to that of Eylea in the TENAYA and LUCERNE trials that compared its safety and efficacy with Eylea.

 

Its duration of response lasted 24 months.

 

In other words, Vabysmo achieved comparable efficacy to other treatments with once every 4 months dosing compared to the once every 1-2 month dosing required for other treatments.