What Formycon does

Formycon AG is a German, publicly listed (Frankfurt Prime Standard, FYB) independent developer of biosimilars founded in 2010 and headquartered in Planegg-Martinsried near Munich. The company operates across the full biosimilar value chain — from candidate selection and protein analytics through process development, clinical trials, and regulatory approval — and has converted that capability into three commercially approved products: FYB201 (ranibizumab, biosimilar to Lucentis) marketed as Ranivisio/CIMERLI/Nufymco, FYB202 (ustekinumab, biosimilar to Stelara) marketed as Otulfi/Fymskina, and FYB203 (aflibercept, biosimilar to Eylea) marketed as AHZANTIVE/Baiama, the last of which launched in Europe in May 2026 with a US launch scheduled for Q4 2026 following a settlement of patent litigation with Regeneron and Bayer. The pipeline contains four additional candidates, led by FYB206 (pembrolizumab/Keytruda biosimilar, positive Dahlia PK data in Q1 2026) and FYB208 (dupilumab/Dupixent biosimilar, analytical comparability milestone November 2025).

Formycon generates revenue through a partnership-led commercialization model rather than a direct salesforce: it licenses or supplies approved products to regional specialists — Teva, Klinge Biopharma, Fresenius Kabi, Coherus BioSciences in Europe and the US, Zydus (US/Canada), Lotus Pharmaceutical (APAC), MS Pharma (MENA), Actor Pharma (Australia), Megalabs (LATAM), Horus Pharma (select EU) — earning milestone payments on development and regulatory achievements, gross-profit share on launch, and direct revenue share on US sales of CIMERLI and Nufymco. The lead development asset, FYB201, is jointly developed with Bioeq AG under a 50% at-equity investment relationship. End customers are healthcare systems and patients requiring affordable biologic therapies in ophthalmology (wet AMD, DME, CNV, RVO), immunology (psoriasis, Crohn's, ulcerative colitis), and oncology (Keytruda-referenced indications).

For financial scale and governance, Formycon reported Q1 2026 revenue of EUR 13.1M (+147% YoY versus EUR 5.3M in Q1 2025), narrowed its Q1 2026 EBITDA loss to EUR -1.7M (from EUR -13.2M), and guided FY 2026 revenue to EUR 60-70M with an EBITDA range of EUR 0-10M — implying a transition to sustainable EBITDA profitability in 2026. Working capital stood at EUR 66.4M as of March 31, 2026 (EUR 70.1M at end-2025), supplemented by a EUR 82.84M strategic investment from Gedeon Richter in January 2024 (9.08% stake) and a 2025/2029 corporate bond. The shareholder structure is diversified: ATHOS KG ~24.3%, Wendeln & Cie. KG ~13.6%, Gedeon Richter ~9.0%, Active Ownership Corporations ~6.0%, DSP Beteiligungsgesellschaft ~5.0%, founders/management ~5.9%, and free float ~36.2%.

Name

Formycon

Legal name

Formycon AG

Website

https://formycon.com

Company type

Public

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Short description

Formycon AG is a Frankfurt-listed independent German biosimilar developer that takes candidates from protein analytics through regulatory approval and licenses them to regional partners (Teva, Zydus, Lotus, Coherus, Fresenius Kabi, MS Pharma) for global commercialization in ophthalmology, immunology, and oncology.

Ownership category

akta.pro rank

Product category

Biosimilars

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Growth Hormone Biosimilars (HLAIAFAH)

Keywords

• Biosimilar development
• Biopharmaceutical manufacturing
• Protein analytics
• Biosimilar pipeline
• Biopharma partnerships

Headquarters

HQ city

Martinsried

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Milestone payments: Formycon receives milestone payments from partners for development achievements including regulatory approvals, clinical milestones, and regional partnership signings. For example, Zydus partnership includes mid-teens-million-euro upfront and milestone payments plus mid-double-digit share of gross profits upon launch.
2. Direct commercialization revenue: Revenue from direct participation in commercialization of approved biosimilars. For FYB201, Formycon receives direct revenue share from US market (CIMERLI/Nufymco brands). For FYB202, revenue from direct participation in marketing.
3. Profit sharing from partnerships: Formycon receives a share of gross profits from commercialization partners upon product launch. The Zydus deal includes mid-double-digit percentage share of gross profits for FYB206 in US/Canada.

Go-to-market motion1 record

Distribution channels7 records

Marketing channels6 records

Core offering

Formycon is an independent developer of high-quality biosimilars, covering the entire value chain from biosimilar candidate selection through analytical development, clinical trials, regulatory approval, and delivery of market-ready products. The company develops ranibizumab (Lucentis biosimilar), ustekinumab (Stelara biosimilar), aflibercept (Eylea biosimilar), and pembrolizumab (Keytruda biosimilar) candidates for ophthalmology, immunology, and oncology indications, commercializing through regional pharmaceutical partners worldwide.

Product overview

Formycon AG is a leading independent developer of high-quality biosimilars covering the entire value chain from biosimilar candidate selection through development to approved, market-ready products. The company has three approved biosimilars on the market: FYB201/Ranibizumab (biosimilar to Lucentis), FYB202/Ustekinumab (biosimilar to Stelara), and FYB203/Aflibercept (biosimilar to Eylea). Four additional biosimilar candidates are in development including FYB206/Pembrolizumab (Keytruda biosimilar), FYB208/Dupilumab (Dupixent biosimilar), FYB209, and FYB210. The company operates a multi-partner commercialization model, partnering with companies including Teva, Klinge Biopharma, Fresenius Kabi, Bioeq, and others for global distribution. Products target therapies in ophthalmology (anti-VEGF treatments) and immunology (autoimmune diseases). Formycon also provides a medical information portal (MedInfo) for patients and healthcare professionals.

Differentiator

Problem solved

Functional benefit

Brands

• Ranivisio: Brand name for FYB201/Ranibizumab biosimilar in certain markets
• Fymskina
• Nufymco
• CIMERLI

Products and services

• FYB201 (Ranibizumab) Biosimilar to Lucentis (ranibizumab) for treating retinal diseases including wet AMD, DME, CNV, and RVO. Marketed as CIMERLI (Coherus BioSciences) and Nufymco (Formycon) in the US, and as Ranivisio in Europe through Teva and Fresenius Kabi.
• FYB202 (Ustekinumab) Biosimilar to Stelara (ustekinumab) for treating psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Available as Otulfi (Fresenius Kabi) and Fymskina (Formycon) in various markets, in 45mg/90mg pre-filled syringes and 130mg concentrate for infusion.
• FYB203 (Aflibercept) Biosimilar to Eylea (aflibercept) for treating serious retinal diseases including wet AMD, DME, CNV, and RVO. Marketed as AHZANTIVE and Baiama in Europe by Klinge Biopharma GmbH; US launch expected Q4 2026.
• FYB206 (Pembrolizumab) Biosimilar candidate to Keytruda (pembrolizumab) for oncology indications including melanoma, NSCLC, and other cancers. Development nearing completion with positive pharmacokinetic equivalence data demonstrating comparability to reference drug.
• FYB208 (Dupilumab) Biosimilar candidate for Dupixent (dupilumab) targeting chronic inflammatory diseases including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. Demonstrated high analytical comparability to reference drug.
• FYB209 Biosimilar candidate in Formycon's development pipeline.
• FYB210 Biosimilar candidate in Formycon's development pipeline.

Quantifiable outcome

• Global biosimilar market expected to grow from ~$21 billion to over $74 billion by 2030
• +2 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

13 partnerships are on record, tiered core, major and minor.

• Lotus PharmaceuticalcoreChannel Partner/ Reseller/ Distributor · 11 February 2026Exclusive license agreement for FYB206 (pembrolizumab biosimilar) covering major parts of Asia-Pacific region. Formycon receives upfront payment, contingent milestone payments, and share of gross profits. Builds on prior collaboration for aflibercept biosimilar AHZANTIVE.
• Zydus LifesciencescoreChannel Partner/ Reseller/ Distributor · 9 December 2025Exclusive licensing and supply agreement for FYB206 (pembrolizumab biosimilar) in US and Canada. Formycon develops, registers, manufactures and supplies; Zydus handles commercialization. Deal includes mid-teens-million-euro upfront and milestone payments with mid-double-digit share of gross profits upon launch.
• MS PharmamajorChannel Partner/ Reseller/ Distributor · 4 December 2025Exclusive licensing and supply agreement for commercialization of FYB206 (Keytruda biosimilar) in Middle East and North Africa region. Collaboration aims to increase access to cancer drug with potential for future expansion and technology transfer.
• Klinge Biopharma GmbHcoreChannel Partner/ Reseller/ DistributorSemi-exclusive commercialization agreement for AHZANTIVE (aflibercept biosimilar) in Europe. Settlement with Regeneron and Bayer secured European market entry for AHZANTIVE and Baiama beginning May 2026.
• Teva Pharmaceutical IndustriescoreChannel Partner/ Reseller/ DistributorLaunched AHZANTIVE (aflibercept biosimilar) in Europe in May 2026 across France, Germany, Spain, and Netherlands with plans to expand. Teva is executing its 'Pivot to Growth' strategy with this biosimilar launch.
• Bioeq AGcoreStrategic or Co-development Partner50% at-equity investment partner for FYB201 (ranibizumab biosimilar). Joint development partner with Formycon for Lucentis biosimilar. Development and commercialization collaboration for FYB201 and other biosimilar products.
• Fresenius KabimajorChannel Partner/ Reseller/ DistributorCommercialization partner for FYB202 (Stelara biosimilar) marketed as Otulfi in select countries. Also involved in launching Ranivisio, the first Lucentis biosimilar in Europe.
• Actor PharmaminorChannel Partner/ Reseller/ DistributorLicensing agreement for aflibercept biosimilar commercialization in Australia.
• MegalabsminorChannel Partner/ Reseller/ DistributorLicensing agreement for aflibercept biosimilar commercialization in Latin America.
• Horus PharmaminorChannel Partner/ Reseller/ DistributorLicensing agreement for aflibercept biosimilar commercialization in selected European countries.
• Coherus BioSciencesmajorChannel Partner/ Reseller/ DistributorCommercialization partner for CIMERLI brand of ranibizumab biosimilar FYB201 in US market. Formycon re-entered US market with CIMERLI in Q1 2026 with Nufymco brand planned for H2 2026.
• Regeneron PharmaceuticalsminorOthersSettled all patent disputes regarding EU-approved aflibercept biosimilars AHZANTIVE and BAIAMA referencing Eylea. Biosimilars may be launched in Europe and other markets beginning May 2026. US litigation separately settled with Q4 2026 US launch date.
• BayerminorOthersSettled European patent disputes with Formycon and Klinge Biopharma regarding aflibercept biosimilars AHZANTIVE and Baiama, enabling May 2026 European market entry.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Celltrion: South Korean biosimilar developer with multiple approved products across immunology (Remsima, Truxima, Herzuma) and oncology - directly comparable as a pure-play biosimilar developer competing for share on overlapping reference molecules.
• Samsung Bioepis: South Korean biosimilar developer with approved products for Eylea (Opuviz), Lucentis (Byooviz), Stelara (Pyzchiva), and others. Directly overlaps with Formycon's portfolio across ophthalmology and immunology reference products.
• Alvotech: Iceland-based biosimilar developer with approved biosimilars for Eylea (Yesafili), Stelara (Selarsdi), and others. Direct competitor across multiple reference molecules targeted by Formycon.
• Biocon Biologics: India-based global biosimilar developer with approved biosimilars across oncology, immunology, and ophthalmology. Direct peer operating with similar therapeutic-area focus and partnership-driven commercialization in many markets.
• Bioeq AG: Swiss biosimilar developer and 50% at-equity joint venture partner of Formycon. Co-develops FYB201 and shares development and commercialization responsibilities - direct peer with substantial operational overlap.
• Coherus BioSciences: US-based biosimilar developer and Formycon's commercialization partner for CIMERLI. Operates its own biosimilar portfolio (Cimerli, Udenyca, Yusimry) - directly comparable and operationally intertwined through the partnership.
• Mabxience: Spanish biosimilar developer focused on oncology and immunology. Direct peer developing and commercializing biosimilars across similar therapeutic categories as Formycon with comparable scale and partnership-led business model.

Broad incumbents

• Sandoz (Novartis): Largest global biosimilar business with a broad portfolio across immunology, ophthalmology, and oncology. Established market leader whose scale and commercial reach Formycon competes against in target markets.
• Amgen: Major biologic manufacturer with biosimilars (Amjevita, Mvasi, Kanjinti) alongside proprietary biologics. Competes with Formycon's biosimilars while operating at materially greater scale and scope.

Regional players

• Stada Arzneimittel: German-headquartered pharmaceutical company with a biosimilar portfolio including Eylea (via Alvotech partnership) and Stelara biosimilars. Operates in the same European markets as Formycon with comparable product overlap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/formycon
• LinkedInlinkedin.com/company/formycon
• Facebookfacebook.com/profile.php

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors2 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Formycon