Formycon
Formycon AG is a leading independent biosimilar developer dedicated to improving access to high-quality, affordable biological medicines. The company operates globally, focusing on ophthalmology, immunology, oncology, and other therapeutic areas. It covers the entire value chain from technical development, clinical trials, regulatory approval, to market launch. With a strong emphasis on innovation, quality, and sustainability, Formycon aims to deliver cost-effective treatment options and expand access to biosimilars worldwide.
Industries
Nr. of Employees
medium (51-250)
Patents
Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US-11666632-B2
View DetailsPre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US-11298405-B2
View DetailsPre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US-10925927-B2
View Details
Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US-11666632-B2
View DetailsPre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US-11298405-B2
View DetailsPre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US-10925927-B2
View DetailsProducts
FYB201 (ranibizumab biosimilar)
Ranibizumab biosimilar developed for ophthalmology (intravitreal administration); partner-managed commercialization in multiple regions. US commercialization has been paused temporarily by the US marketing partner to reposition the product; availability and launches in Europe, MENA and other regions continue with planned introduction of a prefilled syringe to support further market penetration.
FYB202 (ustekinumab biosimilar)
Ustekinumab biosimilar for immunology indications developed for subcutaneous and IV administration; approved and launched in key markets including the USA and the EU, with ongoing commercialization and market-positioning activities together with partners.
FYB203 (aflibercept biosimilar)
Aflibercept biosimilar candidate for ophthalmology indications; regulatory approvals obtained in several jurisdictions and commercial partnerships established for European, MENA and APAC regions. Full global launch timing is subject to agreement with the reference product manufacturer and partners; earliest realistic market introduction expected in 2026 in some territories.
FYB206 (pembrolizumab biosimilar candidate)
Pembrolizumab biosimilar candidate targeting oncology immunotherapy; development strategy emphasizes extensive analytical comparability and continuation of Phase I programs while avoiding a Phase III study based on regulatory scientific advice, accelerating development and reducing costs.
Early-stage biosimilar pipeline candidates (FYB208, FYB209, FYB210)
Multiple additional biosimilar candidates in early development with capability to achieve technical proof-of-similarity and progress into clinical phases upon milestone achievement.
FYB201 (ranibizumab biosimilar)
Ranibizumab biosimilar developed for ophthalmology (intravitreal administration); partner-managed commercialization in multiple regions. US commercialization has been paused temporarily by the US marketing partner to reposition the product; availability and launches in Europe, MENA and other regions continue with planned introduction of a prefilled syringe to support further market penetration.
FYB202 (ustekinumab biosimilar)
Ustekinumab biosimilar for immunology indications developed for subcutaneous and IV administration; approved and launched in key markets including the USA and the EU, with ongoing commercialization and market-positioning activities together with partners.
FYB203 (aflibercept biosimilar)
Aflibercept biosimilar candidate for ophthalmology indications; regulatory approvals obtained in several jurisdictions and commercial partnerships established for European, MENA and APAC regions. Full global launch timing is subject to agreement with the reference product manufacturer and partners; earliest realistic market introduction expected in 2026 in some territories.
FYB206 (pembrolizumab biosimilar candidate)
Pembrolizumab biosimilar candidate targeting oncology immunotherapy; development strategy emphasizes extensive analytical comparability and continuation of Phase I programs while avoiding a Phase III study based on regulatory scientific advice, accelerating development and reducing costs.
Early-stage biosimilar pipeline candidates (FYB208, FYB209, FYB210)
Multiple additional biosimilar candidates in early development with capability to achieve technical proof-of-similarity and progress into clinical phases upon milestone achievement.
Services
End-to-end development services covering CMC, analytical comparability, bioanalytical support, clinical program execution and regulatory dossier preparation for biosimilars.
Routine and development-stage analytical testing including glycan analysis, mass spectrometry (peptide mapping, subunit/intact mass), protein spectroscopy and cell-based potency assays to support similarity assessment, stability and release testing.
Regulatory submission preparation and authority engagement services, including negotiation of biosimilar-specific pathways, use of scientific advice to adapt clinical requirements, and inspection readiness support.
Establishment and management of GMP-aligned Quality Management Systems for analytical and GMP QC laboratories, including SOPs, internal audits, change control and CAPA processes to maintain inspection readiness.
Services to support product launch planning, licensing negotiations, payer engagement, reimbursement coding and implementation of patient support programs, coordinated with commercialization partners.
End-to-end development services covering CMC, analytical comparability, bioanalytical support, clinical program execution and regulatory dossier preparation for biosimilars.
Routine and development-stage analytical testing including glycan analysis, mass spectrometry (peptide mapping, subunit/intact mass), protein spectroscopy and cell-based potency assays to support similarity assessment, stability and release testing.
Regulatory submission preparation and authority engagement services, including negotiation of biosimilar-specific pathways, use of scientific advice to adapt clinical requirements, and inspection readiness support.
Establishment and management of GMP-aligned Quality Management Systems for analytical and GMP QC laboratories, including SOPs, internal audits, change control and CAPA processes to maintain inspection readiness.
Services to support product launch planning, licensing negotiations, payer engagement, reimbursement coding and implementation of patient support programs, coordinated with commercialization partners.
Expertise Areas
- Biosimilar development and CMC
- Analytical and functional protein characterization
- Bioanalytical method development for PK/PD/immunogenicity
- Clinical pharmacokinetic and pivotal comparability trial design
Key Technologies
- Mass spectrometry for protein analytics (ESI‑MS, peptide mapping, intact mass)
- N-glycan analysis by HILIC-UPLC
- Protein spectroscopy (FTIR, CD, nanoDSF)
- Cell-based potency assays
News & Updates
The biosimilar FYB202/Otulfi™ (Ustekinumab) has been launched in Canada following regulatory approval, expanding access to treatment for inflammatory diseases.
The FDA has approved FYB202/Otulfi® as an interchangeable biosimilar for Ustekinumab, enabling automatic substitution in the US.
The company announced positive financial results for Q1 2025, reflecting progress in biosimilar development, market launches, and strategic partnerships.
An interview discussing biosimilar market dynamics and pricing strategies, highlighting the competitive landscape.
A summary of Formycon’s operational highlights, product approvals, and strategic milestones in 2024.
FYB201, a biosimilar for Lucentis®, has been approved in the US, EU, UK, and 19 countries, establishing a strong market presence.
The biosimilar FYB202/Otulfi™ (Ustekinumab) has been launched in Canada following regulatory approval, expanding access to treatment for inflammatory diseases.
The FDA has approved FYB202/Otulfi® as an interchangeable biosimilar for Ustekinumab, enabling automatic substitution in the US.
The company announced positive financial results for Q1 2025, reflecting progress in biosimilar development, market launches, and strategic partnerships.
An interview discussing biosimilar market dynamics and pricing strategies, highlighting the competitive landscape.
A summary of Formycon’s operational highlights, product approvals, and strategic milestones in 2024.
FYB201, a biosimilar for Lucentis®, has been approved in the US, EU, UK, and 19 countries, establishing a strong market presence.