Biogen(BIIB)
CAMBRIDGE, MA
Biotechnology1 H-1B visas (FY2023)Focus: Small Molecules, Biologics, Biosimilars, ASO
Biogen is a life sciences company focused on Small Molecules, Biologics, Biosimilars, ASO.
NeuroscienceRare DiseasesImmunology
Funding Stage
PUBLIC
Employees
7,500
Open Jobs
274
Products & Portfolio (12)
ADUHELM
aducanumab-avwa
Peak
mAbINJECTION · INJECTABLE
2021
30
AVONEX
interferon beta-1a
LOE Approaching
INTRAMUSCULAR · VIAL
12.1 Mechanism of Action The mechanism of action by which AVONEX exerts its effects in patients with multiple sclerosis is unknown. 12.2 Pharmacodynamics Interferons (IFNs) are a family of naturally occurring proteins, produced by eukaryotic cells in response to viral infection and other biologic agents. Three major types of interferons have been defined: type I (IFN-alpha, beta, epsilon, kappa and omega), type II (IFN–gamma) and type III (IFN-lambda). Interferon-beta is a member of the type I subset of interferons. The type I interferons have considerably overlapping but also distinct biologic activities. The bioactivities of all IFNs, including IFN-beta, are induced via their binding to specific receptors on the membranes of human cells. Differences in the bioactivities induced by the three major subtypes of IFNs likely reflect differences in the signal transduction pathways induced by signaling through their cognate receptors. Interferon beta exerts its biological effects by binding to specific receptors on the surface of human cells. This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers. These include 2', 5'-oligoadenylate synthetase, β 2 -microglobulin, and neopterin. These products have been measured in the serum and cellular fractions of blood collected from patients treated with AVONEX. Clinical studies conducted in multiple sclerosis patients showed that interleukin 10 (IL-10) levels in cerebrospinal fluid were increased in patients treated with AVONEX compared to placebo. Serum IL-10 levels maximally were increased by 48 hours after intramuscular injection of AVONEX and remained elevated for 1 week. However, no relationship has been established between absolute levels of IL-10 and clinical outcome in multiple sclerosis. 12.3 Pharmacokinetics Pharmacokinetics of AVONEX in multiple sclerosis patients have not been evaluated. The pharmacokinetic and pharmacodynamic profiles of AVONEX in healthy subjects following doses of 30 micrograms through 75 micrograms have been investigated. Serum levels of AVONEX as measured by antiviral activity are slightly above detectable limits following a 30 microgram intramuscular dose, and increase with higher doses. After an intramuscular dose, serum levels of AVONEX generally peak at 15 hours post-dose (range: 6-36 hours) and then decline at a rate consistent with a 19 (range: 8-54) hour elimination half-life. Subcutaneous administration of AVONEX should not be substituted for intramuscular administration as there is no data establishing that subcutaneous and intramuscular administration of AVONEX result in equivalent pharmacokinetic and pharmacodynamic parameters. Biological response markers (e.g., neopterin and β 2 -microglobulin) are induced by AVONEX following parenteral doses of 15 micrograms through 75 micrograms in healthy subjects and treated patients. Biological response marker levels increase within 1
multiple sclerosis
1996
30
PLEGRIDY
peginterferon beta-1a
Peak
INJECTION · INJECTABLE
12.1 Mechanism of Action The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown. 12.2 Pharmacodynamics There is no biochemical or physiologic effect known to relate directly to the clinical effect of PLEGRIDY. 12.3 Pharmacokinetics After single-dose or multiple-dose subcutaneous administration of PLEGRIDY to healthy subjects, serum PLEGRIDY peak concentration (C max ) and total exposure over time (area under the curve, or AUC) increased in proportion to doses from 63 to 188 micrograms. PLEGRIDY did not accumulate in the serum after multiple doses of 125 micrograms every 14 days. Pharmacokinetic parameters for PLEGRIDY, including C max and AUC, did not differ significantly between healthy volunteers and multiple sclerosis patients or between single-dose and multiple-dose administrations. However, the coefficient of variation between individual patients for AUC, C max , and half-life was high (41% to 68%, 74% to 89%, and 45% to 93%, respectively). Absorption After 125 microgram subcutaneous doses of PLEGRIDY in multiple sclerosis patients, the maximum concentration occurred between 1 and 1.5 days, the mean C max was 280 pg/mL, and the AUC over the 14 day dosing interval was 34.8 ng.hr/mL. Distribution In multiple sclerosis patients taking 125 microgram subcutaneous doses of PLEGRIDY every 14 days, the estimated volume of distribution was 481 liters. Metabolism and Elimination Clearance mechanisms for PLEGRIDY include catabolism and excretion. The major pathway of elimination is renal. The half-life is approximately 78 hours in multiple sclerosis patients. The mean steady state clearance of PLEGRIDY is approximately 4.1 L/hr. PLEGRIDY is not extensively metabolized in the liver. The pharmacokinetics of 125 μg single dose of PLEGRIDY administered subcutaneously and intramuscularly were similar. Specific Populations Body weight, gender, and age do not require dosage adjustment. Renal impairment can increase the C max and AUC for PLEGRIDY. Results of a pharmacokinetic study in patients with mild, moderate, and severe renal impairment (creatinine clearance 50 to 80, 30 to 50, and less than 30 mL/minute, respectively) showed increases above normal for C max of 27%, 26%, and 42%, and for AUC, increases of 30%, 40%, and 53%. The half-life was 53, 49, and 82 hours in patients with mild, moderate, and severe renal impairment, respectively, compared to 54 hours in normal subjects. In the same study, subjects with end stage renal disease requiring hemodialysis two or three times weekly had AUC and C max of PLEGRIDY values that were similar to those of normal controls. Each hemodialysis session removed approximately 24% of circulating PLEGRIDY from the systemic circulation [see Use in Specific Populations ( )] .
relapsing forms of multiple sclerosis (MS)to include clinically isolated syndromerelapsing-remitting disease+2 more
2014
30
QALSODY
tofersen
Growth
RNAINTRATHECAL · SOLUTION
2023
0
SKYCLARYS
omaveloxolone
Peak
ORAL · CAPSULE
Cytochrome P450 3A4 Inducers
2023
0
SPINRAZA
nusinersen
Peak
RNAINTRATHECAL · SOLUTION
2016
0
TECFIDERA
dimethyl fumarate
Peak
ORAL · CAPSULE, DELAYED RELEASE
2013
0
TOFIDENCE
tocilizumab
Growth
mAbINJECTION · INJECTABLE
Interleukin 6 Receptor Antagonists
2023
30
TYSABRI
natalizumab
LOE Approaching
mAbSINGLE-USE · VIAL
Integrin Receptor Antagonists
2004
30
VUMERITY
diroximel fumarate
Peak
ORAL · CAPSULE, DELAYED RELEASE
2019
0
ZINBRYTA
daclizumab
Peak
mAbINJECTION · INJECTABLE
2016
30
ZURZUVAE
zuranolone
Growth
ORAL · CAPSULE
GABA A Receptor Positive Modulators
2023
0
Pipeline & Clinical Trials
Psychometric Validation of Cognitive Endpoints
Multiple SclerosisClinical Trials (1)
NCT01335633Psychometric Validation of Cognitive Endpoints
N/AN/A
Clinical Trials (5)
NCT01591551NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
Phase 4NCT00744679A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
Phase 4NCT01058005Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis
Phase 3+2 more
Evaluation of Brain Atrophy in CIS Patients on Avonex
Multiple SclerosisClinical Trials (1)
NCT01592474Evaluation of Brain Atrophy in CIS Patients on Avonex
N/Anatalizumab
Multiple SclerosisClinical Trials (1)
NCT02137109Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
N/AMulticenter Observational Study of Myotonic Dystrophy Type 1
Myotonic Dystrophy Type 1Clinical Trials (1)
NCT02308657Multicenter Observational Study of Myotonic Dystrophy Type 1
N/AScan-Rescan Sub-Study of MS PATHS
Multiple SclerosisClinical Trials (1)
NCT04123353Scan-Rescan Sub-Study of MS PATHS
N/ATysabri
Multiple SclerosisClinical Trials (1)
NCT01071512Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
N/Anatalizumab
Relapsing-Remitting Multiple SclerosisClinical Trials (1)
NCT01485003Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
N/AThe Myelin Disorders Biorepository Project
LeukodystrophyTysabri®
Multiple SclerosisClinical Trials (1)
NCT01070823JC-Virus (JCV) Antibody Program
N/Adimethyl fumarate
Multiple SclerosisClinical Trials (1)
NCT02047097Dimethyl Fumarate (DMF) Observational Study
N/AOutpatient Muscle Biopsy
SarcopeniaClinical Trials (1)
NCT02839460A Prospective Study Of Biomarkers Of Skeletal Muscle Atrophy
N/ASystemic Sclerosis Clinical and Biomarker Study
HealthyClinical Trials (1)
NCT02531009Systemic Sclerosis Clinical and Biomarker Study
N/AThecaFlex DRx System
Spinal Muscular AtrophyClinical Trials (1)
NCT05866419Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
N/ASC Peginterferon beta-1a
Multiple Sclerosis, Relapsing-RemittingClinical Trials (1)
NCT03347370A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
N/Apeginterferon beta-1a
Relapsing Forms of Multiple SclerosisClinical Trials (1)
NCT02230969Plegridy Observational Program
N/ADigiCog
Multiple SclerosisClinical Trials (1)
NCT04756700Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
N/AGenomic Translation for Amyotrophic Lateral Sclerosis Care
ALSClinical Trials (1)
NCT02795897Genomic Translation for Amyotrophic Lateral Sclerosis Care
N/ASkin Taping
Atopic DermatitisClinical Trials (1)
NCT02125695Pilot Tape Harvesting Study
N/AInterferon beta-1a
Multiple SclerosisClinical Trials (5)
NCT00915460Open-Label Safety Extension Study of Avonex
Phase 4NCT00574041How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
Phase 4NCT00915577Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe
Phase 3+2 more
Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Va
Multiple Sclerosis (MS)Clinical Trials (1)
NCT05197699Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study
N/AOmaveloxolone
Friedreich AtaxiaClinical Trials (1)
NCT06628687A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
N/AGenetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Progressive Multifocal LeukoencephalopathyClinical Trials (1)
NCT01211639Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
N/AThis is a registry.
Dementia DisorderN/A
Clinical Trials (1)
NCT05304520A Study for Tysabri Participant Preference
N/AAvonex® monotherapy
Multiple SclerosisClinical Trials (1)
NCT00463710Effect of Interferon Beta-1a (Avonex®) on Changes of Non-conventional MRI Measures in Patients With MS
N/AMultiple Sclerosis Performance Test
Multiple SclerosisClinical Trials (1)
NCT03926637Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis
N/AKonectom platform
Multiple Sclerosis (MS)Clinical Trials (1)
NCT05106465A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and Magnetic Resonance Imaging (MRI) Measures of Brain Tissue Damage
N/ARisdiplam
Spinal Muscular Atrophy (SMA)Clinical Trials (1)
NCT06978985Adult SMA Research and Clinical Hub
N/ADimethyl fumarate
Multiple SclerosisClinical Trials (1)
NCT01911767Biogen Multiple Sclerosis Pregnancy Exposure Registry
N/Anatalizumab
Multiple SclerosisClinical Trials (1)
NCT02386566Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab
N/ACommunication with the clinic
Multiple SclerosisClinical Trials (1)
NCT02454907The Use of Technology to Improve MS Clinical Trials and Patient Care
N/AUnderstanding Clinical Phenotype and Collecting Biomarker Samples in C9ORF72 ALS
C9ORF72 Amyotrophic Lateral Sclerosis (ALS)Clinical Trials (1)
NCT02686268Understanding Clinical Phenotype and Collecting Biomarker Samples in C9ORF72 ALS
N/ACanadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis
Relapsing-Remitting Multiple SclerosisClinical Trials (1)
NCT01706107Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
N/ARituximab
Non-Hodgkin's LymphomaClinical Trials (1)
NCT00387023Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma
N/ANusinersen Sodium Injection
Muscular Atrophy, SpinalClinical Trials (1)
NCT04317794Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
N/ABenepali
Rheumatoid ArthritisClinical Trials (1)
NCT03327454Benepali® PEN Patient Satisfaction Survey
N/ANusinersen Sodium Injection
Muscular Atrophy, SpinalClinical Trials (1)
NCT04419233Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
N/AMulticenter Validation of The Evergreen Myometric Strength Test for Lower Extremities (EMST-LE) in M
Multiple SclerosisClinical Trials (1)
NCT02369224Multicenter Validation of The Evergreen Myometric Strength Test for Lower Extremities (EMST-LE) in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics
N/AAvonex
Multiple SclerosisClinical Trials (3)
NCT01156298Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance
N/ANCT01641120Assessing Tolerability of Avonex Intramuscular Injections
N/ANCT00675883COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
N/ALongitudinal Data Collection in Pediatric and Adult Patients With Spinal Muscular Atrophy in Latin A
Spinal Muscular AtrophyClinical Trials (1)
NCT05475691Longitudinal Data Collection in Pediatric and Adult Patients With Spinal Muscular Atrophy in Latin America
N/ADimethyl Fumarate
Multiple Sclerosis, Relapsing-RemittingClinical Trials (1)
NCT04221191Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
N/AMR Imaging
HealthyClinical Trials (1)
NCT03218111Glymphatic Kinetics In Healthy Adult Volunteers
N/Anatalizumab
Relapsing Multiple SclerosisClinical Trials (1)
NCT01070836JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
N/ANatalizumab
Multiple SclerosisClinical Trials (1)
NCT05925049A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)
N/Adimethyl fumarate
Relapsing Forms of Multiple SclerosisClinical Trials (1)
NCT01903291Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
N/AAVONEX PEN
Multiple SclerosisClinical Trials (1)
NCT01405872Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.
N/Anatalizumab
Crohn's DiseaseClinical Trials (1)
NCT00707512CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
N/APharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient C
Multiple SclerosisClinical Trials (1)
NCT01070719Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort
N/AInfliximab
Arthritis, RheumatoidClinical Trials (1)
NCT03662919One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study
N/AOpen Jobs (274)
Associate Director, Marketing, Patient Engagement- Rare Disease
Cambridge, MA
4d ago
$164K - $226K/yr
Manager, Patient Services (Limited Duration)
Toronto, Canada
4d ago
From $109K/yr
Executivo de Contas de Doenças Raras - São Paulo/SP - Vaga Afirmativa PCD
Sao Paulo, Brazil
4d ago
Director, Clinical Operations Program Leadership (COPL)
Cambridge, MA
4d ago
$209K - $288K/yr
(Sr) Medical Science Liaison, Rare Diseases / SMA (f/m/d)
Munich, Germany
4d ago
LATAM Digital & Omnichannel Engagement Lead
Buenos Aires, Argentina
4d ago
Director, Strategy & Operations (Biogen North America)
Cambridge, MA
4d ago
$195K - $269K/yr
Executive Assistant & Office Manager
Toronto, Canada
4d ago
Clinical Trial Application Lead, Biogen West Coast Hub
San Francisco, CA
4d ago
$118K - $158K/yr
Sr. Manager, Global Regulatory Affairs- West Coast Hub
Remote
4d ago
$132K - $176K/yr
Global Markets Team Lead, People Relations - UK or Ireland
Maidenhead, United Kingdom
4d ago
Head of Patient Marketing, Lupus
Cambridge, MA
5d ago
$234K - $322K/yr
Sr Manager- QC Validation Transfer and Registration for Biochemistry
Research Triangle Park, NC
5d ago
$131K - $175K/yr
Field Director, Medical Science Liaisons - Lupus
Field Locations
5d ago
$222K - $305K/yr
Access Management Service Delivery Manager
Remote
5d ago
$160K - $220K/yr
Director, Access and Reimbursement- Rare Disease
Remote
5d ago
$199K - $274K/yr
Payment Specialist - Clinical Trial Financial Operations
Remote
5d ago
$95K - $124K/yr
Research Fellow: HTE Medicinal Chemistry
Cambridge, MA
5d ago
From $110K/yr
Global Diagnostics and Disease Area Strategist, Alzheimer’s
Cambridge, MA
5d ago
$234K - $322K/yr
Internship - Vendor Master Data
Warsaw, Poland
5d ago
Associate Director, Strategy & Operations - Specialty Franchise
Cambridge, MA
6d ago
$161K - $222K/yr
Associate Director Forecasting-Lupus/MS
Cambridge, MA
6d ago
$162K - $223K/yr
Sr. Manager, Clinical Trial Lead
Remote
6d ago
$131K - $175K/yr
Associate Director, Regulatory Affairs Advertising and Promotion
Remote
6d ago
$144K - $206K/yr
Associate Director, Data Management & Stewardship
Cambridge, MA
6d ago
$176K - $242K/yr
Interview Prep Quick Facts
Portfolio: 12 approved products, 154 clinical trials
Top TAs: Neurology, Oncology, Immunology
H-1B (2023): 1 approval
Publications: 25 in PubMed
SEC Filings: 2 available
Open Roles: 274 active jobs
Portfolio Health
Growth3 (25%)
Peak7 (58%)
LOE Approaching2 (17%)
12 total products
Therapeutic Area Focus
Neurology
4 marketed305 pipeline
Oncology
59 pipeline
Immunology
1 marketed50 pipeline
Rare Diseases
1 marketed28 pipeline
Nephrology
25 pipeline
Metabolic Diseases
10 pipeline
Cardiovascular
1 marketed6 pipeline
Ophthalmology
7 pipeline
Marketed
Pipeline
Hiring Trend
Actively Hiring
274
Open Roles
+241
Added
-7
Filled/Removed
Based on last 4 crawl cycles
Visa Sponsorship
Sponsors Work Visas
H-1B Petitions (FY2023)
1
Approved
0
Denied
100%
Rate
Source: USCIS H-1B Employer Data Hub