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FDA approves EYLEA biosimilar for serious retinal diseases

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Formycon AG and Klinge Biopharma GmbH have received FDA approval for FYB203/AHZANTIVE (aflibercept-mrbb), a biosimilar to aflibercept 2 mg injection—also known as EYLEA (Regeneron, Inc.).

Let’s start with these companies.

Headquartered in Munich, Germany, Formycon is an independent developer of biosimilars within the biopharmaceutical space.

Its therapeutic focus includes a biosimilar pipeline for key disease areas such as:

  • Ophthalmology
  • Immunology
  • Immuno-oncology

In ophthalmology: The company's FYB201/ranibizumab biosimilar—a biosimilar of Lucentis (Genentech, a member of the Roche Group)—developed in partnership with Bioeq AG—which has already received market approval within Europe and the United States, with a reported five other candidates currently in development.

And Klinge Biopharma?

The Bavaria, Germany-based pharmaceutical company specializes in pharmaceutical and medicine as well as chemical manufacturing.

To note: Klinge has served as a licensing partner in the development of FYB203/AHZANTIVE.

  • Plus: AHZANTIVE is also noted as a registered trademark of Klinge.

Hold up… didn’t we just hear about other EYLEA biosimilars’ approval?

We did—two, actually. However, those were for two different companies:

In May 2024, Biocon Biologics Limited and Samsung Bioepis / Biogen, Inc. were granted FDA approval for the first-to-file application of YESAFILI (aflibercept-jbvf) and OPUVIZ (aflibercept-yszy), respectively.

A key note regarding these approvals: Unlike EYLEA, YESAFILI and OPUVIZ are not indicated for retinopathy of prematurity (ROP), which the brand-name version was FDA approved for in February 2023.

Gotcha. Now talk about this latest biosimilar.

The approval of this biosimilar of EYLEA follows the FDA’s acceptance of the companies’ abbreviated Biologics License Application (aBLA) In August 2023.

How does it work?

Just as with EYLEA—a vascular endothelial growth factor (VEGF) inhibitor approved by the FDA in 2011—the biosimilar uses aflibercept to suppress the formation of blood vessels within the retina (which could lead to vision impairment) and is delivered via an intravitreal injection.

Company note: Formycon stated it is currently working to develop its own proprietary application system for administering the drug to the eye.

And the indications?

The biosimilar is indicated for the following:

  • Neovascular (wet) age-related macular degeneration (nAMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (DR)

What’s the recommended dosage?

It varies, depending on the disease indication. For instance:

  • Wet AMD: the 2 mg (0.05 mL of 40 mg/mL solution) biosimilar is intended to be intravitreally administered every 8 weeks following an initial monthly dose for 3 months.
  • Macular edema following RVO: 2 mg injected once every 4 weeks.
  • DME and DR: 2 mg injected every 4 weeks for the first five injections, then 2 mg once every 8 weeks.

See here for EYLEA’s full prescribing information (PI).

Are there any associated adverse reactions to be aware of?

A few. While the PI for FYB203/AHZANTIVE is not currently available, it’s safe to say it will likely share similarities to EYLEA’s PI.

Per the EYLEA PI, participants in eight phase 3 clinical studies (for five different indications) reported the most common adverse events (AEs) occurring in greater than or equal to 5% of patients:

  • Conjunctival hemorrhage
  • Eye pain
  • Cataract
  • Vitreous detachment
  • Vitreous floaters
  • Increase in intraocular pressure (IOP)

See here (and scroll to 6.1 Clinical Trials Experience) for a breakdown of AEs by indication and studies.

Speaking of clinical trial data, is there any on this biosimilar?

There is! According to Formycon, the biosimilar’s FDA approval was based on a “thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing.”

  • Study details: Positive preliminary efficacy and safety data from the phase 3 MAGELLAN-AMD trial (NCT04522167) were published in February 2023.
    • Further: ”FYB203/AHZANTIVE demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug EYLEA in patients with (wet AMD),” the company reported.

So… when will FYB203/AHZANTIVE be available in the U.S.?

No official word yet, so stay tuned for launch info later this year!

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