What Generium does

Generium is a Russian full-cycle biopharmaceutical company founded in 2008 and headquartered in Moscow, operating an integrated biotechnopark in Volginsky (Vladimir Region) that combines a research institute, preclinical and clinical trial capabilities, and high-tech manufacturing. The company develops both biosimilars and original innovative drugs using recombinant DNA technology, CHO cell lines, and advanced therapy platforms including gene therapy (AAV9 vectors) and oligonucleotide synthesis. Its marketed portfolio spans orphan diseases (MPS II/VI, SMA, Gaucher, PNH), autoimmune conditions (rheumatoid arthritis, psoriasis, multiple sclerosis), oncology, cardiovascular (thrombolytics), and ophthalmology, with several products described as world's first biosimilars or original therapies — notably Clotilia (verenafusp alfa), the first approved drug to use insulin receptor-mediated transcytosis to cross the blood-brain barrier for Hunter syndrome. The company also produces diagnostic medical equipment (SCREENSPOT ELISPOT analyzer for tuberculosis) and operates a pipeline of 30+ medications in development.

Generium distributes products entirely through Russian state healthcare channels: federal and regional government procurement, the Circle of Goodness Foundation (an exclusive supplier relationship for SMA and other orphan disease funding), direct hospital/clinic supply, and open tenders. Pricing is set via government procurement rather than commercial channels, and select products (e.g., Vapromin/risdiplam) are listed on the ЖНВЛП (vital and essential drugs) list. The company employs 1,900+ personnel across 8,000 m² of laboratory space and 61,000 m² of production facilities, and in October 2025 opened the Generium-Next plant in the Alabushevo special economic zone (Moscow), adding 28,000+ m² and capacity for 5.4 million vials per year. International activity is nascent, limited to a clinical trial site in Belarus for GNR-097 gene therapy in Duchenne muscular dystrophy.

Name

Generium

Legal name

АО «ГЕНЕРИУМ» (Joint Stock Company GENERIUM)

Website

https://generium.ru

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Generium is a Russian full-cycle biopharmaceutical company that develops biosimilars and innovative drugs for orphan, autoimmune, oncological, and cardiovascular diseases, distributing entirely through Russian state healthcare procurement and the Circle of Goodness Foundation.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Manufacturing (Biosimilars and Gene Therapy)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Viral Vector Manufacturing Services (AAV, lentiviral, adenoviral) (HLAAAKAD)

akta.pro secondary industries

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ), Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream) (HLAAACAN)

Keywords

• Biopharmaceutical manufacturing
• Biosimilar development
• Orphan disease therapies
• Gene therapy drugs
• Recombinant protein production

Headquarters

HQ city

Moscow

HQ country

Russia

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Revenue generated from sales of biopharmaceutical drugs including biosimilars, generics, and innovative therapies for orphan diseases, oncology, and autoimmune conditions. Products are supplied to Russian healthcare institutions through government procurement and the Circle of Goodness Foundation.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

Generium is a full-cycle Russian biotechnology company that researches, develops, and manufactures genetically engineered biopharmaceutical products. It produces biosimilars and original biologics — including monoclonal antibodies, enzymes, antisense oligonucleotides, coagulation factors, and gene therapies — for orphan diseases (MPS II, MPS VI, SMA, Gaucher, PNH, aHUS), autoimmune conditions, oncology, cardiovascular disease, and ophthalmology, distributed primarily to Russian government healthcare programs and hospitals. It also operates a domestic microplate analyzer (SCREENSPOT) and TB diagnostic reagent system.

Product overview

Generium is a Russian innovative biotechnology company operating as an integrated biotechnopark that combines a world-class research institute, preclinical and clinical trial control centers, and high-tech manufacturing facilities. The company's product portfolio spans multiple categories: (1) pharmaceutical products including biosimilars and original drugs for orphan diseases (MPS II, MPS VI, SMA, Gaucher disease), autoimmune conditions (rheumatoid arthritis, psoriasis, multiple sclerosis), oncology, and cardiovascular diseases (thrombolytics); (2) diagnostic systems including the SCREENSPOT microplate analyzer for tuberculosis testing and TigraTest TB reagent kits; and (3) a robust pipeline of gene therapies and biosimilars in development. Manufacturing capabilities include blood coagulation factors, cytokines, antibodies, enzymes, allergens, and ATMPs (Advanced Therapy Medicinal Products). The company operates from facilities in Volginsky (Vladimir Region) and Alabushevo (Moscow Special Economic Zone), producing approximately 5.4 million vials annually.

Differentiator

Problem solved

Functional benefit

Products and services

• Clotilia® (verenafusp alfa) Original innovative biologic for Hunter syndrome (MPS II) that crosses the blood-brain barrier via insulin-receptor-mediated transcytosis, delivering iduronate-2-sulfatase directly to the central nervous system. Indicated for patients aged 6+ with Hunter syndrome.
• Readeli® (galsulfase) Biosimilar of recombinant N-acetylgalactosamine-4-sulfatase (galsulfase) for enzyme replacement therapy in patients with Mucopolysaccharidosis Type VI (Maroteaux-Lamy syndrome). Restores enzyme activity to hydrolyze accumulated dermatan sulfate.
• Elizaria® (eculizumab biosimilar) Biosimilar of eculizumab, a humanized monoclonal antibody that binds complement protein C5. Indicated for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). 50 patients with aHUS received Elizaria® through an early-access program, including 26 children saved from death.
• Lantesens® (nusinersen) First Russian-developed generic nusinersen — an antisense oligonucleotide that increases survival motor neuron (SMN) protein levels to prevent disease progression in spinal muscular atrophy (5q SMA). Over 200 injections have been administered across dozens of Russian regions.
• Glurazyme® (imiglucerase biosimilar) Biosimilar of recombinant beta-glucocerebrosidase (imiglucerase) for enzyme replacement therapy in patients with Gaucher disease types 1 and 3. The only Russian company producing an imiglucerase biosimilar.
• Complarate® (tocilizumab biosimilar) First Russian-registered biosimilar of tocilizumab, a humanized monoclonal antibody binding the IL-6 receptor. Indicated for rheumatoid arthritis, systemic juvenile idiopathic arthritis, severe COVID-19, and cytokine release syndrome.
• Styleikin® (ustekinumab biosimilar) First Russian-developed biosimilar of ustekinumab — a fully human monoclonal antibody targeting IL-12 and IL-23 — for plaque psoriasis and psoriatic arthritis in adults and children.
• Limiris® (canakinumab biosimilar) First Russian-developed biosimilar of canakinumab — a human monoclonal antibody targeting interleukin-1β — for autoinflammatory fever syndromes, Still's disease, systemic juvenile idiopathic arthritis, and gouty arthritis.
• Tigerase® (dornase alfa biosimilar) First-in-the-world biosimilar of recombinant human deoxyribonuclease I (dornase alfa), which cleaves extracellular DNA in bronchial secretions to improve lung function in patients with cystic fibrosis.
• Continia® (aflibercept biosimilar) First Russian-developed biosimilar of aflibercept — a recombinant fusion protein inhibiting VEGF — for ophthalmic diseases including wet AMD, diabetic macular edema, retinal vein occlusion macular edema, and myopic choroidal neovascularization.
• Laxolan® (ranibizumab biosimilar) Biosimilar of ranibizumab — a non-glycosylated recombinant antibody fragment targeting VEGF-A — for wet AMD, diabetic macular edema, proliferative diabetic retinopathy, macular edema from retinal vein occlusion, and choroidal neovascularization.
• Vapromin® (risdiplam) Risdiplam — an SMN2 splicing modifier — for the treatment of spinal muscular atrophy. Included in the Russian list of vital and essential medicines (ЖНВЛП).
• Koagil-VII® (eptacog alfa [activated]) Eptacog alfa [activated] — recombinant activated factor VII identical to human factor VIIa. Universal hemostatic agent for hemophilia with inhibitors, acquired hemophilia, factor VII deficiency, Glanzmann thrombasthenia, and postpartum hemorrhage.
• Genolair® (omalizumab biosimilar) Omalizumab biosimilar — an anti-IgE monoclonal antibody — for allergic asthma and chronic idiopathic urticaria. Marketed in both lyophilizate and solution dosage forms.
• Nekteliza® (tenecteplase biosimilar) Biosimilar of tenecteplase — a fibrin-specific plasminogen activator — for thrombolytic therapy of acute myocardial infarction and ischemic stroke in adults, administered as a single bolus injection.
• Reveliza® (alteplase biosimilar) Biosimilar of alteplase — tissue plasminogen activator — for thrombolytic therapy.
• Efiktel® (natalizumab biosimilar) Biosimilar of natalizumab — a monoclonal antibody targeting α4-integrin — for relapsing forms of multiple sclerosis and Crohn's disease.
• Infibeta® (interferon beta-1b) Recombinant interferon beta-1b for the treatment of relapsing forms of multiple sclerosis.
• Stimplate® (romiplostim biosimilar) Romiplostim biosimilar — a thrombopoietin receptor agonist — for the treatment of immune thrombocytopenia.
• SCREENSPOT microplate analyzer Medical device — a Russian-developed microplate analyzer for automated reading and analysis of tuberculosis test results based on the ELISPOT method. Production capacity up to 300 units per year via the Troitsk Engineering Center partnership.
• TigraTest TB reagent kit Test system for tuberculosis diagnosis using the ELISPOT method to assess cellular immunity (IGRA methodology). Used with the SCREENSPOT analyzer in clinical diagnostic laboratories.
• GNR-097 (Duchenne muscular dystrophy gene therapy) Gene therapy drug for Duchenne muscular dystrophy using a recombinant adeno-associated viral vector of serotype 9 encoding a truncated dystrophin gene. Currently in Phase 1/2 multicenter clinical trial in boys aged 4-9 in Russia and Belarus.

Quantifiable outcome

• Over 200 injections of Lantesens® administered to patients with spinal muscular atrophy across dozens of Russian regions
• +6 more outcomes

Named customers10 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Troitsk Engineering CentercoreStrategic or Co-development Partner · 1 January 2025Full-cycle project for SCREENSPOT microplate analyzer development. Troitsk Engineering Center engineers collaborated with Generium biotechnologists. Software-hardware complex and reagents are entirely Russian development. The Troitsk Engineering Center produces SCREENSPOT analyzers with capacity up to 300 units per year.
• Sputnik V ProductionminorStrategic or Co-development Partner · 1 January 2021Launch of production for Sputnik V COVID-19 vaccine as part of Russia's vaccination campaign.
• SG BiotechcoreStrategic or Co-development Partner · 1 January 2008Joint venture established in 2008 for biotechnological development and production activities.
• Global Biotechnology Companies and Research InstitutesminorStrategic or Co-development PartnerScientific research is conducted jointly with biotechnology companies and scientific institutes from around the world. No specific named partners listed.

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Biocon: India's leading biosimilar manufacturer (trastuzumab, bevacizumab, insulin glargine) with global commercialization partnerships. Closely comparable to Generium in business model: biosimilar-led biologics manufacturer with growing novel biologics pipeline.
• Celltrion: Korea's largest biosimilar developer (infliximab, rituximab, trastuzumab, bevacizumab) with vertical manufacturing. Comparable to Generium's biosimilar strategy and full-cycle development approach.
• Stada Arzneimittel: European specialty pharma and biosimilar company focused on generics, biosimilars (including teriparatide, pegfilgrastim, adalimumab), and consumer health. Comparable diversified biosimilar portfolio and emerging-markets manufacturing footprint.
• Pharmstandard: Largest Russian pharmaceutical manufacturer by volume with a broad branded generics and OTC portfolio. Overlaps with Generium in state drug procurement programs and serves as a benchmark for domestic pharma scale in Russia.

Direct peers

• BIOCAD: Russia's largest domestic biotechnology company developing biosimilars (rituximab, bevacizumab, adalimumab, etanercept, trastuzumab) and innovative biologics. Direct competitor to Generium in the Russian orphan, autoimmune, and oncology biosimilar segments with overlapping government procurement exposure.
• R-Pharm: Major Russian pharmaceutical and biotechnology company with branded generics, biosimilars, and contract manufacturing. Competes with Generium for Russian government tenders, healthcare procurement, and talent in the biologics space.
• Sarepta Therapeutics: U.S. gene therapy leader for Duchenne muscular dystrophy with ELEVIDYS (delandistrogene moxeparvovec), an AAV-based therapy. Direct therapeutic competitor to Generium's GNR-097 AAV9-microdystrophin program in DMD.

Emerging players

• Samsung Bioepis: Samsung-Biogen joint venture developing biosimilars of etanercept, infliximab, adalimumab, ranibizumab and others. Comparable to Generium's biosimilar pipeline breadth and monoclonal antibody manufacturing capabilities.
• Alvotech: Icelandic biosimilar specialist developing adalimumab, ustekinumab, aflibercept, and other biosimilars. Comparable to Generium in targeting biosimilars of complex biologics including monoclonal antibodies and recombinant enzymes, with vertically integrated manufacturing.

Regional players

• Polpharma Biologics: Polish biosimilars developer and CDMO with WHO-GMP manufacturing facilities across Europe. Comparable to Generium as a mid-size European/CIS biosimilar manufacturer focused on monoclonal antibodies and recombinant proteins for global markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubevkvideo.ru/@generiumru
• LinkedInlinkedin.com/company/ibc-generium

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

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

Frequently asked questions about Generium