Actor Pharmaceuticals and Megalabs Partner to Market Formycon’s Eylea® Biosimilar FYB203 in Australia and Latin America

Formycon’s Eylea Biosimilar Gains Ground in Australia and Latin America with New Partnerships

Planegg-Martinsried, Germany – October 16, 2025 – Formycon AG today announced strategic partnerships to broaden the reach of its Eylea^® biosimilar, FYB203 (aflibercept), into key international markets. These collaborations mark a significant step in expanding access to this critical treatment for severe retinal conditions.

Expanding Market Reach: Australia and Latin America

Klinge Biopharma GmbH, the licensee and marketing rights holder for FYB203, finalized an exclusive licensing agreement with Actor Pharmaceuticals pty.Ltd. to commercialize the biosimilar in Australia.Simultaneously, a separate exclusive agreement with Megalabs SA will drive the rollout of FYB203 throughout Latin America. This dual expansion is poised to address unmet needs in regions grappling with rising rates of retinopathies.

Financial Implications of the Partnerships

Under the terms of these agreements, Klinge Biopharma will receive a combination of upfront payments, milestone-based payments, and a percentage of net sales. Formycon will benefit through a mid-single to low-double-digit percentage share of all payments made to Klinge. Furthermore, Formycon will oversee the supply chain for FYB203 and receive service fees, along with volume-based profit sharing for commercial deliveries.

Addressing a Growing Global Health Concern

nicola Mikulcik, Chief Business Officer of Formycon AG, emphasized the growing prevalence of severe retinopathies, fueled by demographic shifts and increasing diabetes diagnoses, which can lead to considerable vision impairment. She stated that these partnerships will make the biosimilar more accessible as a cost-effective therapy,reducing the financial strain on healthcare systems and improving patient care.

Key Partners: Actor Pharmaceuticals and Megalabs

Actor Pharmaceuticals, an Australian firm, specializes in the approval and marketing of innovative medicines and biosimilars. Megalabs, based in Uruguay, possesses a strong presence throughout the Americas, notably known for its biotech innovations and biosimilar development. Both companies bring extensive market knowledge and robust networks to these collaborations.

Did You know? according to a report by Grand view Research, the global biosimilars market was valued at USD 20.96 billion in 2023 and is projected to reach USD 73.86 billion by 2030, growing at a CAGR of 19.3% from 2024 to 2030.

Regulatory Progress and Future Outlook

FYB203 has already secured regulatory approvals in the United States, Europe, and the United kingdom. The application for approval in Australia is currently under review by the Therapeutic Goods Management (TGA). Formycon is working alongside Megalabs to prepare submissions to regulatory bodies throughout Latin America.

Region	Commercialization Partner	Approval Status (as of oct 16, 2025)
Australia	Actor Pharmaceuticals	Application Submitted to TGA
Latin America	Megalabs SA	applications in Preparation
United States	Klinge Biopharma	Approved (June 2024)
Europe	Klinge Biopharma	Approved (January 2025)
United Kingdom	Klinge Biopharma	Approved (February 2025)

About Eylea^® and Aflibercept

Eylea^® (Aflibercept) is a widely used treatment for neovascular age-related macular degeneration (nAMD) and other serious retinal diseases. Its active component works by inhibiting vascular endothelial growth factor (VEGF), which contributes to abnormal blood vessel formation in the retina.

The Growing Importance of Biosimilars

biosimilars are playing an increasingly vital role in healthcare by offering more affordable alternatives to expensive biologic drugs. These drugs undergo rigorous testing to ensure they are highly similar to the original biologic,providing comparable safety and efficacy. This increased competition can lower healthcare costs and expand patient access to life-changing treatments.

Pro Tip: When evaluating biosimilars,patients and healthcare providers should consult reputable sources of information,such as the U.S. Food and Drug Administration (FDA) website, to understand the scientific basis for thier approval and ensure confidence in their use.

Frequently Asked Questions about Formycon and FYB203

What are your thoughts on the expanding role of biosimilars in global healthcare? Do you believe these partnerships will significantly improve access to critical treatments?

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What are the key benefits of increased biosimilar competition, specifically regarding patient access and healthcare costs, as highlighted in the partnership between Actor Pharmaceuticals and Megalabs?

Actor Pharmaceuticals and Megalabs Expand Access to Eylea® Biosimilar FYB203 in Australia & Latin America

Strategic Partnership for Enhanced Ophthalmology Care

Actor Pharmaceuticals and Megalabs have announced a notable partnership to commercialize Formycon’s Eylea® (aflibercept) biosimilar, FYB203, across Australia and key Latin American markets.This collaboration aims to broaden patient access to a cost-effective treatment option for various retinal diseases, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). The agreement leverages Megalabs’ established commercial infrastructure and Actor Pharmaceuticals’ expertise in biosimilar progress and distribution.

FYB203: A Closer Look at the biosimilar

FYB203 is a biosimilar to regeneron’s Eylea®, a blockbuster biologic used to treat several vision-threatening conditions. Biosimilars are highly similar to the original biologic drug, offering comparable safety and efficacy at a perhaps lower cost. This is crucial in ophthalmology, where frequent intravitreal injections are often required, making treatment expenses substantial for both patients and healthcare systems.

* Mechanism of Action: FYB203, like Eylea®, works by inhibiting vascular endothelial growth factor (VEGF), a protein that promotes abnormal blood vessel growth in the eye.

* Target Indications: The primary indications for FYB203 include:

* Wet Age-related macular Degeneration (Wet AMD)

* Diabetic Macular Edema (DME)

* Retinal Vein Occlusion (RVO)

* Clinical Trial Data: Formycon has demonstrated through rigorous clinical trials that FYB203 exhibits comparable efficacy and safety profiles to the reference product, Eylea®.

Market Dynamics in Australia and Latin America

The demand for ophthalmic treatments, particularly for retinal diseases, is steadily increasing in both Australia and Latin America due to aging populations and rising rates of diabetes.

Australia

Australia’s healthcare system, with its emphasis on global access, presents a strong possibility for biosimilars like FYB203. The Pharmaceutical Benefits Scheme (PBS) plays a key role in determining reimbursement and uptake of new medications.Triumphant PBS listing will be critical for widespread adoption.

Latin America

Latin American markets, including Brazil, Mexico, and Argentina, are experiencing growing healthcare expenditure and a rising prevalence of chronic diseases. The introduction of FYB203 offers a chance to alleviate the financial burden of treatment for patients and healthcare providers. However, navigating diverse regulatory landscapes and market access requirements will be essential.

The Role of Actor Pharmaceuticals and Megalabs

This partnership combines the strengths of both companies:

* actor Pharmaceuticals: Specializes in the development and commercialization of complex generics and biosimilars. Their focus on quality and regulatory compliance ensures a reliable product supply.

* Megalabs: Possesses a robust distribution network and strong relationships with healthcare professionals throughout Latin America and Australia. Their market expertise will be instrumental in driving adoption of FYB203.

Benefits of Increased Biosimilar Competition

The entry of FYB203 into the Australian and Latin American markets is expected to yield several benefits:

* Cost Savings: Biosimilars typically offer significant cost savings compared to originator biologics, making treatment more affordable.

* Increased Access: Lower costs can expand access to essential ophthalmic care for a larger patient population.

* Healthcare System Relief: Reduced treatment expenses can alleviate the financial strain on healthcare systems.

* Stimulated Innovation: Competition from biosimilars encourages innovation in the pharmaceutical industry.

Regulatory pathways and approvals

Successful commercialization hinges on securing regulatory approvals in each target country. Both Australia’s Therapeutic Goods Management (TGA) and the regulatory agencies in Latin American nations have established pathways for biosimilar approval, requiring demonstration of comparability to the reference product. Megalabs and Actor Pharmaceuticals are actively working to navigate these processes.

Future Outlook: Biosimilars in Ophthalmology

The global biosimilars market is projected to continue its rapid growth, with ophthalmology representing a significant segment. As more biosimilars become available, competition will intensify, driving down prices and improving patient access to life-changing treatments. The partnership between Actor Pharmaceuticals and Megalabs is a prime exmaple of how strategic collaborations can accelerate the adoption of biosimilars and transform the landscape of ophthalmic care.