Regeneron Pharmaceuticals, Inc. operates as an integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.
The company's products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
The company's core business strategy...
Regeneron Pharmaceuticals, Inc. operates as an integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.
The company's products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
The company's core business strategy is to maintain a strong foundation in scientific research and drug development using its proprietary technologies, and to build on that foundation with its clinical development, manufacturing, and commercial capabilities.
Products
Certain products have also received marketing approval in countries outside the United States, European Union (EU), or Japan.
EYLEA HD (aflibercept) Injection 8 mg: Wet age-related macular degeneration ('wAMD'), Diabetic macular edema ('DME'), and Diabetic retinopathy ('DR').
EYLEA (aflibercept) Injection: wAMD; DME; DR; Macular edema following retinal vein occlusion ('RVO'), which includes macular edema following central retinal vein occlusion ('CRVO') and macular edema following branch retinal vein occlusion ('BRVO'); Myopic choroidal neovascularization ('mCNV'); Neovascular glaucoma ('NVG'); and Retinopathy of prematurity ('ROP').
Dupixent (dupilumab) Injection: Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older); Asthma (in adults and adolescents); Asthma (in pediatrics 6-11 years of age); Chronic rhinosinusitis with nasal polyposis (CRSwNP) (in adults); CRSwNP (in adolescents); Chronic obstructive pulmonary disease (COPD); Eosinophilic esophagitis ('EoE') (in adults, adolescents, and pediatrics aged 1 year and older); Prurigo nodularis; and Chronic spontaneous urticaria (CSU) (in adults and adolescents).
Libtayo (cemiplimab) Injection: Metastatic or locally advanced first-line non-small cell lung cancer ('NSCLC'); Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy); Metastatic or locally advanced basal cell carcinoma ('BCC'); Metastatic or locally advanced cutaneous squamous cell carcinoma ('CSCC'); and Metastatic or recurrent second-line cervical cancer.
Praluent (alirocumab) Injection: LDL-lowering in heterozygous familial hypercholesterolemia ('HeFH') or clinical atherosclerotic cardiovascular disease ('ASCVD'); HeFH in pediatrics and adolescents (8-17 years of age); Cardiovascular risk reduction in patients with established cardiovascular disease; and Homozygous familial hypercholesterolemia ('HoFH').
Kevzara (sarilumab) Injection: Rheumatoid arthritis (RA); Polymyalgia rheumatica (PMR); and Polyarticular juvenile idiopathic arthritis (pJIA).
REGEN-COV: COVID-19.
Evkeeza (evinacumab) Injection: HoFH (in adults, adolescents, and pediatrics).
Ordspono (odronextamab): Follicular lymphoma (FL) and Diffuse large B-cell lymphoma (DLBCL).
Inmazeb (atoltivimab, maftivimab, and odesivimab) Injection: Infection caused by Zaire ebolavirus.
Veopoz (pozelimab) Injection: CD55-deficient protein-losing enteropathy (CHAPLE) (in adults, adolescents, and pediatrics aged 1 year and older).
ARCALYST (rilonacept) Injection: Cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) (in adults and adolescents); Deficiency of interleukin-1 receptor antagonist (DIRA) (in adults, adolescents, and pediatrics); and Recurrent pericarditis (in adults and adolescents).
ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion: Metastatic colorectal cancer (mCRC).
Additional Information - Clinical Development Programs
Linvoseltamab
In August 2024, the FDA issued a CRL for the BLA for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies. The sole approvability issue identified related to findings from a pre-approval inspection at a third-party fill/finish manufacturer. In January 2025, the company resubmitted the BLA following resolution of third-party manufacturing issues, and an FDA decision on the BLA is anticipated by mid-2025.
Dupixent
In September 2024, the company and Sanofi announced that the first Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe CPUO did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements) but showed nominally significant improvements in all other itch endpoints. The Dupixent Phase 3 program in CPUO consists of Study A and Study B. Study B recently initiated as a subsequent pivotal trial.
Select Early-Stage Clinical Development Updates
In 2024, a Phase 1 study of linvoseltamab, in combination with dupilumab, in severe food allergy was initiated.
In 2024, a Phase 1 combination cohort of nezastomig and REGN4336 (bispecific antibody targeting PSMA and CD3) in metastatic castration-resistant prostate cancer was initiated.
Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development
EYLEA HD (aflibercept) 8 mg
EYLEA HD is a soluble fusion protein that acts as a vascular endothelial growth factor (VEGF) inhibitor. Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability to treat various retinal diseases, including wAMD, DME, and DR.
Dupixent (dupilumab)
Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that play a major role in atopic dermatitis, asthma, CRSwNP, COPD, EoE, prurigo nodularis, CSU, and potentially other chronic allergic and inflammatory diseases.
Kevzara (sarilumab)
Kevzara is a fully human monoclonal antibody that binds specifically to the IL-6 receptor and inhibits IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with RA and has been associated with disease activity, joint destruction, and other systemic problems.
Itepekimab
Itepekimab is an investigational, fully human monoclonal antibody that inhibits IL-33, a protein that is believed to play a key role in lung inflammation in COPD.
REGN5713-5715
REGN5713-5715 is an investigational combination of two fully human monoclonal antibodies designed to treat allergic inflammatory conditions caused by the allergen Bet v 1, which is the main allergen responsible for birch pollen allergies. Birch pollen allergy is one of the most common causes of seasonal allergies that occur in the spring and is also believed to trigger 'oral allergy syndrome' food reactions to related allergens found in nuts and fruits, such as apples, pears, and cherries.
REGN1908-1909
REGN1908-1909 is an investigational combination of two fully human monoclonal antibodies that is designed to specifically bind and block the Fel d 1 allergen, thus preventing it from binding and triggering the endogenous antibodies that cause allergies (i.e., immunoglobulin E antibodies). Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats.
Libtayo (cemiplimab)
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. The PD-1/PD-L1 immune checkpoint pathway is a well-known mechanism by which cancers evade immune destruction. The company is studying Libtayo as monotherapy and in combination with either conventional or novel therapeutic approaches in various solid tumors and blood cancers. It is also being studied in combination with proprietary anti-cancer assets of other companies. Libtayo has also been approved by regulatory authorities in a number of cancer indications, including advanced NSCLC, BCC, CSCC, and cervical cancer.
Fianlimab
Fianlimab is an investigational, fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T-cells. In melanoma and NSCLC, LAG-3 expression in the tumor microenvironment may be associated with therapeutic resistance to PD-1 inhibitors. Fianlimab is being investigated in combination with Libtayo to determine whether concurrent blockade of LAG-3 and PD-1 can help overcome this resistance and release the brakes on T-cell activation.
Pozelimab
Pozelimab is a fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity and is approved by the FDA for CHAPLE. Pozelimab is being studied in investigational combinations with an investigational small interfering RNA (siRNA) therapy, cemdisiran, in PNH, myasthenia gravis, and geographic atrophy.
Linvoseltamab
Linvoseltamab is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells. The company is studying whether linvoseltamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma. It is also studying linvoseltamab in precursor conditions to multiple myeloma, including high-risk MGUS and high-risk smoldering myeloma.
Nex-z
Nex-z is an investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and is being studied as a treatment for ATTR amyloidosis. ATTR amyloidosis is a progressive and fatal disorder resulting from deposition of insoluble amyloid fibrils into multiple organs and tissues leading to systemic failure. Delivered with in vivo technology, nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent, and potentially lifelong reduction in transthyretin (TTR) protein after a single dose.
Garetosmab
Garetosmab is an investigational, fully human monoclonal antibody that binds to and neutralizes Activin A, which drives the abnormal bone formation that is the main pathology of the ultra-rare genetic disorder FOP. This abnormal bone formation in soft tissue outside of the normal skeleton, a process known as heterotopic ossification, leads to loss of mobility and premature death in FOP patients. Garetosmab is being investigated to determine whether it can help reduce and/or prevent the formation of heterotopic bone lesions by neutralizing the Activin A protein.
Mibavademab
Mibavademab is an investigational, fully human monoclonal antibody that binds to and activates the leptin receptor, which modulates the control of food intake, energy expenditure, and glucose/lipid metabolism. The company is studying mibavademab as a potential treatment for generalized lipodystrophy.
Other Programs
The company's preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, auditory conditions, enzyme replacement therapy, cardiovascular diseases, infectious diseases, and diseases related to aging. These preclinical research programs include both rare diseases and those involving broader populations.
Research and Development Technologies
Many proteins that play an important role in biology and disease are secreted by cells or located on the cell surface. Moreover, cells communicate through secreted factors and surface molecules. The company scientists have developed two different technologies to make protein therapeutics that potently and specifically block, activate, or inhibit the action of specific cell surface or secreted molecules. The first technology fuses receptor components to the constant region of an antibody molecule to make a class of drugs it calls 'Traps.' EYLEA HD, EYLEA, ZALTRAP, and ARCALYST are drugs generated using its Trap technology. VelociSuite is its second technology platform, which is used for discovering, developing, and producing fully human antibodies that can address both secreted and cell-surface targets. The company also leverages VelociSuite to produce new classes of bispecific antibodies. Additionally, it uses genetic medicine platforms as complementary approaches to these core technologies to potentially treat or cure diseases.
VelociSuite
VelociSuite consists of VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, VelociHum, and other related technologies. The VelocImmune mouse platform is utilized to produce fully human antibodies. VelocImmune was generated by leveraging its VelociGene technology, in a process in which six megabases of mouse immunoglobulin gene loci were replaced, or humanized, with corresponding human immunoglobulin gene loci. VelocImmune mice can be used efficiently to generate fully human antibodies to targets of therapeutic interest. VelocImmune and its entire VelociSuite offer the potential to increase the speed and efficiency through which human antibody therapeutics may be discovered and validated, thereby improving the overall efficiency of its early-stage drug development activities. The company is utilizing the VelocImmune technology to produce its next generation of therapeutic antibody drug candidates for preclinical and clinical development.
The company's VelociGene platform allows custom and precise manipulation of very large sequences of DNA to produce highly customized alterations of a specified target gene, or genes, and accelerates the production of knock-out and transgenic expression models. In producing knock-out models, a color or fluorescent marker may be substituted in place of the actual gene sequence, allowing for high-resolution visualization of precisely where the gene is active in the body during normal body functioning, as well as in disease processes. For the optimization of preclinical development and pharmacology programs, VelociGene offers the opportunity to humanize targets by replacing the mouse gene with the human homolog or variants thereof. Thus, VelociGene allows scientists to rapidly identify the physical and biological effects of deleting or over-expressing the target gene, as well as to characterize and test potential therapeutic molecules.
The company's VelociMouse technology platform allows for the direct and immediate generation of genetically altered mice from embryonic stem cells (ES cells), thereby avoiding the lengthy process involved in generating and breeding knockout mice from chimeras. Mice generated through this method are normal and healthy and exhibit a 100% germ-line transmission. Furthermore, mice developed using its VelociMouse technology are suitable for direct phenotyping or other studies.
The company has also developed its VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for its Traps and its VelocImmune human antibodies.
The company has utilized its VelociSuite technologies to develop a class of potential drug candidates, known as bispecific antibodies. Veloci-Bi allows for the generation of full-length bispecific antibodies similar to native antibodies that are amenable to production by standard antibody manufacturing techniques and are likely to have favorable antibody-like pharmacokinetic properties. In the area of immunotherapies in oncology, it is exploring the use of bispecific antibodies that target tumor antigens and the CD3 receptor on T-cells to harness the oncolytic properties of T-cells. The company is exploring additional indications and applications for its bispecific technologies, including CD28 and 4-1BB costimulatory bispecifics. It is also exploring a variety of alternative antibody formats (Altibodies) that can bring binding partners together in restrained geometries.
The VelociT mouse extends its research and drug discovery capabilities into cell-mediated immunity and therapeutic T-cell receptors (TCRs) for oncology and other indications. VelociT was developed by using the company's VelociGene technology to humanize genes encoding TCRAlpha and TCRBeta variable sequences, CD4 and CD8 co-receptors, beta2m, and class-I and -II major histocompatibility complexes. As a result, VelociT mice can be utilized to produce fully human TCRs, providing for customized modeling of T-cell function in different diseases and a powerful platform for the discovery of unique TCR-based therapies. It is also able to produce antibodies that recognize intracellular peptides bound in the groove of human leukocyte antigen (HLA), enabling the targeting of intracellular proteins in cancer cells.
VelociHum is the company's immunodeficient mouse platform that can be used to accurately test human therapeutics against human immune cells and to study human tumor models. Through genetic humanizations, VelociHum mice have been optimized to allow for better development of human immune cells in vivo, as well as to allow for engraftment of primary patient-derived tumors that do not take in other commercially available mice.
Regeneron Genetics Center
Regeneron Genetics Center LLC (RGC), a wholly owned subsidiary of the company, leverages de-identified clinical, genomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness. The objective of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs, with the prospect of improving the drug discovery and development process and to advance innovation in clinical care design. RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts that engage study participants to more discrete disease specific and founder populations with data on strategic phenotypes of interest. RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining nearly 3 million samples sequenced to as of December 31, 2024.
In January 2025, it was announced that RGC was selected by UK Biobank consortium members to complete proteomic assay data generation for the recently announced UK Biobank Pharma Proteomics Project.
In January 2025, RGC entered into an agreement with Truveta Inc. pursuant to which RGC will sequence exomes and conduct genotyping and imputation of up to ten million de-identified consented volunteers using biospecimens provided by Truveta health system members across the United States.
In addition, central to the ongoing work of RGC is the portfolio of collaborations with over 150 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, University of Oxford, and the University of Cambridge. These collaborations provide access to biological samples and associated phenotype data from properly consented patient volunteers for purposes of genomic research. RGC undertakes genetic sequencing of these samples to create a unique resource of de-identified genetic data and associated phenotype data for research. Furthermore, RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping. In addition, RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets. RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics.
These efforts at RGC have led to the identification of more than 30 novel genetic targets. Through its Regeneron Genetics Medicines initiative, it is advancing these targets using either its VelociSuite technologies or other technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.
Collaboration, License, and Other Agreements
Sanofi
The company is collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the Antibody Collaboration).
Under the company's collaboration agreement, Sanofi records product sales for commercialized products, and it has the right to co-commercialize such products on a country-by-country basis. It co-commercializes Dupixent in the United States and in certain countries outside the United States. The company supplies certain commercial bulk product to Sanofi.
Bayer
The company and Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA 8 mg and EYLEA outside the United States. Agreed-upon development expenses incurred by the company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.
Within the United States, the company retains exclusive commercialization rights and are entitled to all profits from such sales.
Alnylam
In 2019, the company and Alnylam entered into a collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.
For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.
The company has entered into various license agreements with Alnylam, with it as the licensee, including for cemdisiran as a monotherapy and for a combination consisting of cemdisiran and pozelimab.
Intellia
The company and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development. Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized). In addition, it has non-exclusive rights to independently develop and commercialize ex vivo gene edited products.
In September 2023, the company expanded the license and collaboration agreement to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases. Intellia will lead the design of the editing methodology, it will lead the design of the targeted viral vector delivery approach, and the parties share costs equally. Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
In October 2023, the company elected to extend the period for selecting targets under the license and collaboration agreement for an additional two years until April 2026.
In March 2024, Intellia elected to opt-out of further development activities pursuant to the Factor IX co-development and co-commercialization agreement; as a result, it retains the right to develop and commercialize products directed to Factor IX (which is in Phase 1 clinical development).
Decibel
In 2017, the company entered into an agreement with Decibel Therapeutics, Inc. to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss).
2seventy bio
In 2018, the company entered into a collaboration agreement with bluebird bio, Inc. (which subsequently spun out 2seventy bio, Inc. in 2021) to research, develop, and commercialize novel cell therapy approaches to address cancer.
In April 2024, the company acquired full development and commercialization rights to 2seventy bio's oncology and autoimmune preclinical and clinical stage cell therapy pipeline.
Commercial
The company's medicines are marketed through its commercial group, which includes experienced professionals in the fields of marketing, sales, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, and market research.
In the United States, the company sells its marketed products primarily to wholesalers and specialty distributors that serve pharmacies, hospitals, government agencies, physicians, and other healthcare providers. It had sales to two customers (Besse Medical, a subsidiary of Cencora, Inc., and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2024. On a combined basis, its product sales to these customers accounted for 74% of its total gross product revenue for the year ended December 31, 2024. The company promotes approved medicines to healthcare professionals via its team of field employees, as well as medical journals, medical exhibitions, distribution of literature and samples, and online channels. In addition, the company advertises certain products directly to consumers and maintain websites with information about its medicines. The commercial group also evaluates opportunities for its targets and product candidates and prepares for market launches of new medicines.
The company has established certain commercial capabilities outside the United States in connection with co-commercializing Dupixent in accordance with its Sanofi collaboration and with obtaining the rights, in 2022, to commercialize Libtayo outside the United States.
Competition
Marketed Products
EYLEA HD and EYLEA: This product's competitors are Amgen Inc., Genentech/Roche, Novartis AG, Samsung Bioepis Co., Ltd., Biogen Inc., Xbrane Biopharma AB and STADA Arzneimittel AG, Formycon AG, Bioeq AG, Sandoz, Teva Ltd., Allergan/AbbVie Inc., and Alimera Sciences, Inc.
Dupixent: This product's competitors are Almirall S.A., Eli Lilly and Company, AbbVie, Galderma; Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd., LEO Pharma Inc., Pfizer, AstraZeneca/Amgen, GlaxoSmithKline (GSK), and Roche/Novartis.
Libtayo: This product's competitors are Merck & Co., Inc., Bristol-Myers Squibb, Roche, AstraZeneca, Pfizer/Merck KGaA, GSK, and Checkpoint Therapeutics, Inc.
Patents, Trademarks, and Trade Secrets
The company's patent portfolio includes granted patents and pending patent applications covering its VelociSuite technologies, including its VelocImmune mouse platform which produces fully human antibodies. The company's remaining issued patents covering these technologies will expire between 2025 and 2032. However, it continues to file patent applications directed to improvements to these technology platforms.
The company's patent portfolio also includes issued patents and pending applications relating to commercialized products and its product candidates in clinical development. These patents cover, among other things, proteins, DNA and RNA molecules, manufacturing patents, method of use patents, and pharmaceutical compositions and formulations.
The company is also the nonexclusive licensee of a number of additional patents and patent applications. These include a license agreement with Bristol-Myers Squibb, E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. to obtain a license under certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.
'Altibodies', 'ARCALYST', 'Evkeeza', 'EYLEA', 'EYLEA HD', 'Inmazeb', 'Libtayo', 'Ordspono', 'Praluent', (in the United States), 'REGEN-COV', 'Regeneron', 'Regeneron Genetics Center', 'RGC', 'Veloci-Bi', 'VelociGene', 'VelociHum', 'VelociMab', 'VelocImmune', 'VelociMouse', 'VelociSuite', 'VelociT', 'Veopoz', and 'ZALTRAP' are trademarks of the company.
Government Regulation
Following approval, the FDA and comparable regulatory authorities outside the United States regulate the marketing and promotion of the company's products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA regulations and standards thereunder and equivalent foreign laws.
In addition, the company and its third-party suppliers are required to maintain compliance with cGMP and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance.
The company is subject to healthcare fraud and abuse laws, such as the federal civil False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations.
The company is subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which it operates, including the U.K. Bribery Act.
Outside the United States, the company's activities subject to additional data protection authority oversight and require it to comply with stringent local and regional data privacy laws. Such laws include the EU's General Data Protection Regulations (GDPR), which has a wide range of compliance obligations relating to the processing and protection of personal data.
In addition to the foregoing, the company's business is subject to regulation under the United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation and Liability Act, the National Environmental Policy Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, national restrictions, and other potential future local, state, federal, and foreign regulations.
History
Regeneron Pharmaceuticals, Inc. was founded in 1988. The company was incorporated in the state of New York in 1988.