Who we are

Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

Contact:
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany
phone +49 (0) 89 - 86 46 67 100 
fax + 49 (0) 89 - 86 46 67 110
info@formycon.com

Biotechnology

Formycon AG

Formycon AG's headquarters in Planegg, Germany

This department oversees quality assurance processes and manages external partnerships to ensure compliance and optimal performance.

Quality Management

The Scientific R&D Team at Formycon AG is responsible for the research and development of high-quality biosimilars and innovative biopharmaceutical medicines. This team performs critical tasks such as mass spectrometry analysis, stability coordination, physicochemical characterization, quality control, and drug product process development. They work collaboratively to advance biopharmaceutical projects from the early stages of technical development through to clinical trials and regulatory submissions, ensuring the creation of vital and affordable treatments for chronic diseases.

Scientific R&D Team

This department focuses on the compliance and regulatory aspects of chemistry, manufacturing, and controls related to drug substances and products.

Regulatory Affairs CMC

The Preclinical and Process Sciences team at Formycon AG focuses on the early stages of biopharmaceutical development, including biosimilars. They handle preclinical studies to assess the safety and efficacy of new treatments and oversee the development and optimization of manufacturing processes. This team ensures that all biopharmaceutical products meet stringent regulatory requirements and maintain high standards of quality and consistency before progressing to clinical trials.

Preclinical and Process Sciences

The Clinical Development and Operations team at Formycon AG oversees the planning, execution, and management of clinical trials for the company’s biopharmaceutical and biosimilar products. This includes designing study protocols, ensuring regulatory compliance, coordinating with clinical research organizations (CROs), and managing clinical trial logistics to ensure timely and cost-effective progression from clinical phase I through phase III, ultimately supporting the submission of dossiers for marketing approval.

Clinical Development and Operations

This department manages employee relations, benefits, and human capital projects to support organizational development.

Human Resources

This department focuses on analyzing project data to drive insights and support decision-making processes.

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Other teams

Scientific R&D Team

Regulatory Affairs CMC

Preclinical and Process Sciences

Clinical Development and Operations

Human Resources

Project Analytics