We develop therapies for serious medical conditions with few or no treatment options.
We develop therapies for serious medical conditions with few or no treatment options.
AVONEX® (interferon beta-1a) has been available for more than 18 years as one of the first prescribed interferon therapies for the treatment of relapsing forms of MS worldwide. AVONEX is approved for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
The most common side effects associated with AVONEX MS treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Rare cases of anaphylaxis have been reported.
FAMPYRA® (prolonged-release fampridine tablets) is a treatment indicated to improve walking in adult patients with multiple sclerosis (MS). Biogen has a license from Acorda Therapeutics, Inc. to develop and commercialize FAMPYRA in all markets outside the United States.
FAMPYRA is the first treatment to both address the unmet medical need of walking improvement in adults living with MS, and demonstrate clinical efficacy in adults with MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs.
In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPRYA was shown to provide a clinically meaningful improvement in walking.
The highest incidence of adverse reactions identified from placebo-controlled trials in MS patients with FAMPYRA, given at the recommended dose, was urinary tract infection (in approximately 12% of patients), although infection was often not proven by culture. Adverse drug reactions identified were mainly divided between neurological disorders, such as insomnia, balance disorder, dizziness, paraesthesia, headache and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Confounding factors may have contributed to the occurrence of seizure in some patients.
For further information on FAMPYRA in your country please click here.
U.S. residents: For information, please visit Acorda Therapeutics.
PLEGRIDY® (peginterferon beta-1a) is approved for the treatment of relapsing forms of MS with a dosing schedule of once every two weeks.
PLEGRIDY contains interferon beta-1a, which is pegylated to extend its half-life. The most common adverse reactions associated with PLEGRIDY treatment are injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus and arthralgia. PLEGRIDY can cause serious side effects, including serious allergic reactions, injection site reactions, heart problems including congestive heart failure, autoimmune diseases, blood problems and changes in your blood tests, and seizures.
TECFIDERA® (dimethyl fumarate) is an oral therapy approved in the United States for the treatment of relapsing multiple sclerosis, which is the most common form of the disease. TECFIDERA has been proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile. Tecfidera is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA and can cause anaphylaxis and angioedema, progressive multifocal leukoencephalopathy (PML), lymphopenia and flushing. The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in nature, and GI events (i.e., diarrhea, nausea, and abdominal pain). These events are most common at the start of therapy and usually decrease over time. Because TECFIDERA may decrease lymphocyte counts, a CBC including lymphocyte count should be obtained before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter.
TECFIDERA is also approved in Canada, Australia, Switzerland and the European Union.
TYSABRI® (natalizumab) is a treatment approved for relapsing forms of MS in adults in the United States and highly active relapsing-remitting MS in adults in the European Union.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses. Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in patients treated with TYSABRI in the postmarketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved
ZINBRYTA® (daclizumab) is approved in the United States for the treatment of relapsing forms of multiple sclerosis (RMS), the most common form of the disease. Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis (MS).
In clinical trials, ZINBRYTA demonstrated superior efficacy across multiple measures of MS disease activity (relapses and MRI) compared to AVONEX® (interferon beta-1a) intramuscular injection and placebo. ZINBRYTA is a once-monthly, self-administered, subcutaneous treatment.
The ZINBRYTA label includes a boxed warning for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders. Because of these risks, access to ZINBRYTA in the United States is restricted to prescribers, pharmacies and patients enrolled in the ZINBRYTA Risk Evaluation and Mitigation Strategy (REMS) Program, which includes required monthly liver function tests.
The most common adverse reactions (incidence at least 5 percent and at least 2 percent higher incidence than comparator) that occurred in ZINBRYTA-treated patients were nasopharyngitis (inflammation of the nose and a part of the throat), upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal (part of the throat) pain, bronchitis, eczema, and lymphadenopathy (enlargement of the lymph nodes) compared with AVONEX; and upper respiratory tract infection, depression, rash, pharyngitis (inflammation of part of the throat), and increased alanine aminotransferase (ALT; a type of liver enzyme) compared with placebo. The U.S. ZINBRYTA prescribing information also includes warnings and precautions for hepatic injury, immune-mediated disorders, acute hypersensitivity (inflammatory reaction), infections, depression and suicide.
Biogen and AbbVie are co-promoting ZINBRYTA in the United States.
With over 30 years of clinical excellence in MS, Biogen is a leader in multiple sclerosis (MS) research. Biogen continues its commitment to patients through ongoing research, solutions and services to support unmet needs in the management of MS. Biogen currently has the broadest MS portfolio in the industry with products that help treat across the spectrum of relapsing forms of MS. Through affordability programs, we are committed to continuing to improve access to products for patients who need them.
Spinal Muscular Atrophy
The U.S. Food and Drug Administration (FDA) approved SPINRAZA® (nusinersen) for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakening.
In ENDEAR, a pivotal controlled clinical study, infantile-onset SMA patients treated with SPINRAZA achieved and sustained clinically meaningful improvement in motor function compared to untreated study participants. In addition, a greater percentage of patients on SPINRAZA survived compared to untreated patients. Open-label studies support the effectiveness of SPINRAZA across a broad range of SMA patients. In these studies, rather than experiencing progressive declines, some patients achieved milestones such as the ability to sit unassisted, stand or walk.
The most common adverse reactions reported for SPINRAZA were upper respiratory infection, lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients. Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides.
We are proud to bring the first treatment to the SMA community who inspire us every day. Biogen is deeply committed to helping improve the lives of people with SMA and we work closely with the SMA patient community with the goal of understanding and incorporating the perspectives of patients and families into the decisions we make. This new treatment is now approved by the United States' Food and Drug Administration and the European Union’s European Medicines Agency. SPINRAZA® availability in the EU will vary by country, per local reimbursement and access pathways. The SMA360 patient assistance program is not applicable in Europe.
BENEPALI® is the first etanercept biosimilar referencing Enbrel® approved in the European Union (EU). BENEPALI® (etanercept) is indicated for adults in the EU to treat:
The European Commission approval was based on a preclinical and clinical data package submitted to the European Medicines Agency (EMA) by Samsung Bioepis. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared BENEPALI to its reference product Enbrel. The primary endpoint showed BENEPALI had a comparable efficacy and a safety profile to Enbrel.
The most commonly reported adverse events were injection site reactions, infections, allergic reactions, development of autoantibodies, itching, and fever. Serious adverse reactions have also been reported, including fatal and life-threatening infections and sepsis, which affected fewer than 1 in 100 patients. Various malignancies have also been reported. Serious hematological, neurological and autoimmune reactions have also been reported, including rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively. There have been rare reports of lupus, lupus-related conditions, and vasculitis.
For further information on BENEPALI in your country please click here.
FLIXABI® is an infliximab biosimilar referencing Remicade® approved in the European Union (EU). FLIXABI is indicated in the EU to treat:
The European Commission approval was based on a preclinical and clinical data package submitted to the European Medicines Agency (EMA) by Samsung Bioepis. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared FLIXABI to its reference product Remicade. Results confirmed FLIXABI has equivalent efficacy and comparable safety and immunogenicity to Remicade. The most commonly reported adverse event in Remicade clinical trials was upper respiratory tract infection, headache, rash, coughing and stomach pain. The most serious reactions reported with the use of Infliximab include: Infusion reactions and hypersensitivity, infections including tuberculosis, sepsis, pneumonia, fungal, viral and other opportunistic infections; Hepatitis B (HBV) reactivation, Hepatobiliary events; Malignancies, such as lymphoma, leukemia, Merkel cell carcinoma, melanoma and pediatric malignancy have been reported; heart failure; haematologic reactions and hSarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn’s disease).
For further information on FLIXABI in your country please click here.
IMRALDI® is an adalimumab biosimilar referencing Humira® approved in the European Union (EU). IMRALDI is indicated in the EU to treat:
The European Commission approval was based on a preclinical and clinical data package submitted to the European Medicines Agency (EMA) by Samsung Bioepis. Confirmatory data from well-controlled, two head-to-head studies- Phase I and Phase III clinical trials compared IMRALDI to its reference product Humira. Results confirmed IMRALDI has equivalent efficacy and comparable safety and immunogenicity to Humira.
The most common adverse reactions reported in clinical trials of adalimumab are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Serious adverse reactions have been reported for adalimumab. TNF-antagonists, such as Humira affect the immune system and their use may affect the body’s defense against infection and cancer.
Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
For further information on IMRALDI® in your country please contact your local affiliate.
Biosimilars are a classification of biologic medicines that are similar to currently available biologic therapies known as originators. Having successfully delivered complex originator biologics for almost 40 years, today Biogen is one of only a handful of companies with the leading manufacturing capabilities and the deep scientific expertise needed to produce biosimilars of advanced biologics. By bridging our heritage of scientific innovation with an opportunity to reduce healthcare costs and increase access to biologics, developing biosimilars is a compelling way in which we can make a difference in the lives of the patients we serve.
Through a joint venture with Samsung Biologics, called Samsung Bioepis Co., Biogen’s biosimilar therapies are marketed in the European Union.
GAZYVA® (obinutuzumab), injection for intravenous infusion, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). The FDA granted GAZYVA breakthrough therapy designation. GAZYVA, formerly known as GA101, was approved by the FDA in November 2013.
CLL is one of the most common forms of blood cancer. Most cases of CLL (95 percent) start in white blood cells called B cells that have a protein called CD20 on their surface.
GAZYVA can cause side effects that can become serious or life-threatening, including hepatitis B reactivation, progressive multifocal leukoencephalopathy (PML), infusion reactions, tumor lysis syndrome (TLS), infections and low blood counts. The most common side effects of GAZYVA are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough and muscle and joint pain. These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist. GAZYVA is available by prescription only.
Please see the full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.
RITUXAN® (rituximab) is approved for treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) as a single agent; for previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens; for previously untreated follicular,
CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy; and for the treatment of nonprogressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.
RITUXAN is also approved for use in combination with methotrexate (MTX) for reducing signs and symptoms and to slow the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
RITUXAN is also approved in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).
RITUXAN has been associated with fatal infusion reactions, tumor lysis syndrome, severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation with related fulminant hepatitis and other serious viral infections, cardiovascular events, renal toxicity and bowel obstruction and perforation.
The most common adverse events in previous trials of RITUXAN in RA were infusion-related symptoms, affecting 32% of patients receiving RITUXAN vs. 23% receiving placebo during the first infusion. The incidence of infusion reactions decreased with each subsequent infusion. The most common reactions included fever, chills/rigor, nausea, asthenia and headache. These reactions generally have resolved with slowing or interruption of the infusion and with supportive care.
We collaborate with Genentech, a member of the Roche Group, on the development and commercialization of RITUXAN®. In addition, in the United States we collaborate with Genentech on GAZYVA®. The Roche Group maintains sole responsibility for the development, manufacturing and commercialization of GAZYVA in the U.S.