Biogen GmbH
Pharmaceutical Companies · München
Biogen GmbH is a pharmaceutical company based in München, Germany.
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Biogen GmbH Address & Contact
Company profile
1978
Founded
7.400+
Employees
Biogen GmbH Overview
Biogen GmbH is the German subsidiary of Biogen Inc., one of the world's leading biopharmaceutical companies focusing on neurology and neuropsychiatric disorders. Biogen Inc. was founded in 1978 in Geneva (Switzerland) as a joint venture of a group of renowned molecular biologists, including Nobel laureates Walter Gilbert and Phillip Sharp. The company is headquartered in Cambridge (Massachusetts, USA) and employs approximately 7,400 people worldwide. Biogen was one of the first biotechnology companies ever and is considered a pioneer in the biotech industry. The German branch is located in Munich and serves the German neurology market, making a significant contribution to healthcare in the field of neurological disorders.
Field of Activity & Products
Biogen is primarily active in Germany in the field of Multiple Sclerosis (MS) and plays a crucial role in the treatment of patients with this chronic disease. The company offers several approved MS therapies:
- Avonex: Interferon beta-1a as an intramuscular injection.
- Plegridy: A pegylated Interferon beta-1a, administered as a subcutaneous injection.
- Tysabri: Natalizumab, an infusion therapy for patients with highly active relapsing-remitting MS.
- Tecfidera: Dimethyl fumarate in tablet form.
- Vumerity: Diroximel fumarate, a newer oral therapy option.
Additionally, Biogen is involved in the field of Spinal Muscular Atrophy (SMA) and markets Spinraza (Nusinersen), the world's first approved therapy for SMA, administered via an intrathecal injection. In light of the demographic change and the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer's, Biogen has intensely researched innovative therapies. With Leqembi (Lecanemab), developed in partnership with Eisai, Biogen offers a novel therapy targeting the amyloid pathology of Alzheimer’s disease.
Research & Regulation
Biogen significantly invests in research and development of novel neurotherapeutic approaches and is known for developing innovative solutions for complex neurological diseases. The company-owned research focuses not only on developing new drugs but also on improving existing therapies to enhance the quality of life for patients. All products are subject to stringent regulatory requirements by the Federal Institute for Drugs and Medical Devices (BfArM) and the European Medicines Agency (EMA). This regulation ensures that the safety and efficacy of therapies are thoroughly tested before they reach the market. Biogen is also a member of the Association of Research-based Pharmaceutical Companies (vfa), underscoring the company's commitment to the highest standards in drug development and production.
Regional Significance & Special Features
The Munich location plays a central role in the regional healthcare economy. As a center for biomedical research and development, Biogen benefits from proximity to leading universities and research institutions. Collaborating with academic partners allows Biogen to be at the forefront of science and develop innovative therapies. Furthermore, the company has launched numerous initiatives to raise awareness of neurological diseases and to provide further education for professionals in the field of neurology.
A particular strength of Biogen GmbH is its commitment to patient care. The company runs special programs to support MS patients, helping them manage their condition more effectively. Additionally, Biogen is dedicated to education and awareness-raising in the public domain to make the challenges associated with neurological diseases transparent.
More information: Pharmaceutical Companies in Bavaria or all pharmaceutical companies in Germany on Sanoliste.
```Frequently asked questions about Biogen GmbH
What does Biogen GmbH in Deutschland do?
Biogen is ein führendes Biotechnologieundernehmen with Fokus on Neurologie. In Deutschland develops and disributes the company innovative Therapien for Multiple Sklerose, ALS, Alzheimer, Spinale Muskelatrophie and weitere schwere neurologische Erkrankungen.
Auf welche Erkrankungen spezialisiert sich Biogen?
Biogen spezialisiert sich on Multiple Sklerose, ALS (Amyotrophe Lateralsklerose), Alzheimer-Krankheit, Spinale Muskelatrophie, Friedreich-Ataxie, postpartale Depression sowie Psoriasis and entzündliche Erkrankungen.
Welche Behandlungsansätze verfolgt Biogen?
Biogen develops innovative Biologika and medicines on Basis biotechnologischer research. The company setzt on wissenschaftliche Grandlagenforschung, um neue Therapien for bisher schwer behandelbare neurologische Erkrankungen zu entwickeln.
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About Pharmaceutical Companies
Germany is one of the world's leading pharmaceutical nations, home to more than 1,000 pharmaceutical businesses employing approximately 130,000 people (vfa 2023). Companies operating in this sector develop, manufacture and distribute medicines across the entire value chain, from early-stage research and clinical trials through to market authorisation and commercial distribution. In Germany, every manufacturer of medicinal products must hold a manufacturing authorisation (Herstellungserlaubnis) issued under Section 13 of the AMG (Arzneimittelgesetz, Germany's Medicinal Products Act). Medicines may only be placed on the market after receiving approval from either BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Germany's Federal Institute for Drugs and Medical Devices, broadly comparable to the FDA in the United States or the MHRA in the United Kingdom) or the European Medicines Agency (EMA) via the centralised procedure. All manufacturing sites are subject to regular GMP (Good Manufacturing Practice) inspections carried out by the competent pharmaceutical supervisory authority of the relevant German federal state. The sector covers prescription-only medicines (Rx), non-prescription OTC products, generics, biosimilars and active pharmaceutical ingredients (APIs). This directory lists pharmaceutical manufacturers, marketers and licence holders across all German federal states with full contact details, addresses and phone numbers.
Germany's Pharmaceutical Industry
Germany is consistently ranked among the top five pharmaceutical markets worldwide, generating annual revenues exceeding EUR 50 billion and accounting for the largest share of pharmaceutical production in continental Europe. The industry is represented by two major associations: vfa (Verband Forschender Arzneimittelhersteller), which represents research-based companies, and BAH (Bundesverband der Arzneimittel-Hersteller), which represents the broader manufacturer base including OTC and self-medication products. German pharmaceutical companies cover the full spectrum from global innovator corporations and mid-sized specialty manufacturers to generic producers and biotech firms. The country is a world leader in active pharmaceutical ingredient (API) production, biologics manufacturing and pharmaceutical chemistry. Key therapeutic areas of strength include oncology, cardiovascular medicine, immunology, neuroscience and rare diseases. Germany also serves as a significant export hub, with pharmaceutical products among the country's leading export categories. The sector benefits from a highly skilled workforce, world-class university research institutions and a dense network of research hospitals (Universitätsklinika) that facilitate clinical trial activity.
Regulatory Framework: BfArM, EMA and the AMG
The legal foundation for pharmaceutical activity in Germany is the Arzneimittelgesetz (AMG, German Medicinal Products Act), which regulates the authorisation, manufacture, import, distribution, labelling and pharmacovigilance of medicinal products. For English-speaking readers unfamiliar with the German regulatory landscape: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is the national competent authority responsible for approving medicines marketed only in Germany, supervising narcotics, and maintaining the pharmacovigilance database. BfArM is a higher federal authority (Bundesoberbehörde) subordinate to the Federal Ministry of Health (Bundesministerium für Gesundheit). For medicines approved via the centralised EU procedure, the European Medicines Agency (EMA) grants a single marketing authorisation valid in all 27 EU member states. Germany is also home to the Paul-Ehrlich-Institut (PEI), a second federal authority that specifically handles biological medicines including vaccines, blood products and gene therapy products. Manufacturing sites are inspected by state-level pharmaceutical supervisory authorities (Landesbehörden) to verify GMP compliance, with findings entered into the EudraGMDP database operated by the EMA.
Regional Pharmaceutical Clusters in Germany
Germany's pharmaceutical industry is geographically distributed across several major regional clusters. The Rhine-Main area around Frankfurt and Leverkusen in North Rhine-Westphalia is home to some of Germany's largest pharmaceutical sites, including facilities belonging to global corporations with long histories in German chemistry and pharmaceuticals. Bavaria (particularly Munich, Penzberg and Marburg) is a second major hub, especially strong in biotechnology and biologics production. Baden-Württemberg, including cities such as Mannheim, Heidelberg and Biberach an der Riss, is home to several significant research-based manufacturers. Hamburg and the northern German region have a cluster of specialty and generic manufacturers. Berlin has a growing biotech scene connected to its research universities and the Charité hospital. Hesse is notable for its proximity to Frankfurt's logistics infrastructure and several major API manufacturers. Smaller but significant clusters exist in Saxony (Leipzig, Dresden) and Lower Saxony, benefiting from proximity to university research centres and historically established chemical industry sites.
Drug Classes and Product Segments
German pharmaceutical companies cover all major drug classes. Prescription (Rx) products account for the largest share of revenue; generics manufacturers such as Stada, ratiopharm (Teva) and Hexal produce chemically equivalent alternatives after patent expiry, significantly reducing costs for the healthcare system. Biologics and biosimilars are gaining ground rapidly: monoclonal antibodies, insulin analogues and recombinant growth factors require specialised biotech manufacturing facilities. OTC products (over-the-counter), i.e. medicines available without a prescription, represent a multi-billion-euro market served by companies such as Bayer Consumer Health, Stada and Klosterfrau. Homeopathic preparations, herbal medicines and dietary supplements form further regulated segments. Digitalisation is increasingly shaping the sector: Digital Health Applications (DiGA) have been reimbursable since 2020, and AI-assisted drug development is significantly shortening time-to-market.
What does a pharmaceutical company do?
Pharmaceutical companies develop, produce and distribute medicines. They cover the entire value chain from research and clinical trials through to market launch and distribution. In Germany, they are supervised by BfArM (the Federal Institute for Drugs and Medical Devices, comparable to the FDA or MHRA).
How are pharmaceutical companies regulated in Germany?
Pharmaceutical companies in Germany must hold a manufacturing authorisation under Section 13 of the AMG (German Medicinal Products Act). All authorised medicines require approval from either BfArM or the European Medicines Agency (EMA). Regular GMP (Good Manufacturing Practice) inspections ensure quality standards are maintained.
Where can I find contact details for pharmaceutical companies in Germany?
Industry associations such as vfa (Association of Research-Based Pharmaceutical Companies) and BPI (Federal Association of the German Pharmaceutical Industry) maintain member directories. Many companies also list their key contacts directly on their websites. Sanoliste provides a searchable directory of pharmaceutical companies in Germany sorted by federal state and city.
How many pharmaceutical companies are there in Germany?
Germany is home to more than 1,000 pharmaceutical companies employing approximately 130,000 people, according to vfa (the Association of Research-Based Pharmaceutical Companies) 2023 data. The sector includes multinational corporations, mid-sized specialty firms, generic manufacturers and biotech startups.
What is BfArM and what does it regulate?
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is Germany's Federal Institute for Drugs and Medical Devices. It is a higher federal authority within the portfolio of the Federal Ministry of Health and is responsible for approving medicines for the German market, monitoring drug safety (pharmacovigilance), regulating narcotics and controlled substances, and overseeing medical devices in Germany. It is broadly comparable to the FDA in the United States or the MHRA in the United Kingdom.
What is the difference between BfArM approval and EMA approval?
Medicines in Germany can be approved through two main routes. BfArM grants national marketing authorisations valid in Germany, or decentralised and mutual recognition procedure approvals valid in multiple EU states. The EMA (European Medicines Agency) grants centralised marketing authorisations valid in all 27 EU member states simultaneously, typically used for innovative biologic medicines, oncology drugs and products for rare diseases.
What does GMP mean in the context of German pharmaceutical manufacturing?
GMP stands for Good Manufacturing Practice. In Germany and the EU, GMP compliance is a legal requirement for all pharmaceutical manufacturers under the AMG and the EU GMP Guidelines (EudraLex Volume 4). GMP covers all aspects of production including premises, equipment, personnel qualification, process validation, documentation and quality control. Compliance is verified by regular inspections from the competent state pharmaceutical supervisory authority.