Biogen Inc. and its subsidiaries (Biogen) is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases.
The company has a broad portfolio of medicines to treat MS, has introduced the first approved treatment for SMA, co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a genetic cause of ALS. The company markets the fir...
Biogen Inc. and its subsidiaries (Biogen) is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases.
The company has a broad portfolio of medicines to treat MS, has introduced the first approved treatment for SMA, co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a genetic cause of ALS. The company markets the first and only drug approved in the U.S. and the E.U. for the treatment of FA in adults and adolescents aged 16 years and older. The company is focused on advancing the company’s pipeline in neurology, specialized immunology and rare diseases. The company supports its drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions.
The company’s marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of FA; QALSODY for the treatment of ALS; and FUMADERM for the treatment of severe plaque psoriasis.
The company also has collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of PPD. The company has certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the option to add other potential anti-CD20 therapies, pursuant to the company’s collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
The company commercializes a portfolio of biosimilars of advanced biologics, including: BENEPALI, an etanercept biosimilar referencing ENBREL; IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, in the U.S. and certain international markets. The company also has commercialization rights related to OPUVIZ, an aflibercept biosimilar referencing EYLEA.
Acquisitions and Divestitures
Human Immunology Biosciences
On July 2, 2024, the company completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases. HI-Bio's lead asset, felzartamab, an anti-CD38 antibody, is being evaluated for three leading indications, AMR, PMN and IgAN. Felzartamab has received Breakthrough Therapy Designation and ODD from the FDA for development in the treatment of PMN and AMR. Subsequent to the company’s acquisition, felzartamab received ODD in the E.U. in IgAN and solid organ transplantation. The acquisition of HI-Bio is expected to augment the company’s pipeline and build on the company’s expertise in immunology.
Sale Of Priority Review Voucher
In April 2024, the company completed the sale of its rare pediatric disease PRV, generated by the development associated with SPINRAZA, to a third party.
Developments In Key Collaborative Relationships
LEQEMBI (lecanemab)
The United States
Key developments related to LEQEMBI in the U.S. consisted of the following:
In January 2025, the FDA approved LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease.
In January 2025, the FDA accepted for review the BLA for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025.
In July 2024, Eisai presented new clinical data from the CLARITY AD study open-label extension of LEQEMBI, demonstrating that three years of continuous LEQEMBI treatment reduced clinical decline, resulting in a clinically meaningful benefit for early Alzheimer's disease patients.
Rest of World
Key developments related to LEQEMBI (lecanemab) in rest of world markets consisted of the following:
In January 2025, the company and Eisai announced an update regarding the ongoing regulatory review of the MAA for lecanemab in the E.U., which the CHMP of the EMA previously adopted a positive opinion on in November 2024. The EC has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.
In December 2024, LEQEMBI was approved by the Federal Commission for the Protection Against Sanitary Risk in Mexico.
In November 2024, the company and Eisai announced the launch of LEQEMBI in South Korea, which had been approved by the Ministry of Food and Drug Safety in South Korea in May 2024.
In October 2024, the Therapeutic Goods Administration of Australia issued a public statement about the initial decision not to register lecanemab. In December 2024, Eisai submitted a request for reconsideration of this decision.
In August 2024, LEQEMBI was approved by the Medicines and Healthcare products Regulatory Agency in Great Britain and by the Ministry of Health and Prevention in the United Arab Emirates.
In July 2024, LEQEMBI was approved in Hong Kong and Israel.
In June 2024, the company and Eisai announced the launch of LEQEMBI in China, which had been approved by the NMPA in China in January 2024.
UCB Collaboration
In September 2024, the company and UCB announced positive topline data from the Phase 3 PHOENYCS GO study of dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe SLE. The Phase 3 study met the primary endpoint demonstrating clinical improvement in moderate-to-severe SLE with clinical improvements observed among key secondary endpoints. Based on these results, UCB and Biogen initiated a second Phase 3 study in late 2024.
Product and Pipeline Developments
Neurology
Alzheimer's Disease
LEQEMBI (lecanemab)
In October 2024, Eisai presented data on benefits of long-term administration of dual-acting LEQEMBI at the 2024 CTAD conference. The data presented additional measures resulting from the three years of continuous LEQEMBI treatment, showing that 46% of patients improved or had no decline and 33% showed improvement from baseline on the CDR-SB. On the ADAS-Cog14 measurement scale, 46% of patients showed improvement or no decline and 43% showed improvement. On the ADCS MCI-ADL measurement scale, 51% of patients showed improvement or no decline and 48% showed improvement.
In July 2024, Eisai announced the results of a detailed analysis of the Phase 3 CLARITY Alzheimer's disease study of LEQEMBI at the 2024 AAIC conference. The study provided further Phase 3 analysis showing three years of continuous LEQEMBI treatment reduced clinical decline by -0.95 on CDR-SB showing continued clinically and personally meaningful benefit for early Alzheimer's disease patients.
Immunology
Felzartamab
Felzartamab was granted ODD in the E.U. in IgAN and solid organ transplantation in November 2024 and December 2024, respectively.
In October 2024, the company presented complete results from the Phase 2 IGNAZ study evaluating felzartamab, an investigational anti-CD38 monoclonal antibody, in people living with IgAN during the American Society of Nephrology Kidney Week 2024. The results from the study showed substantial reductions in proteinuria, stabilization of kidney function and sustained treatment effect more than 18 months after the last dose of felzartamab.
In October 2024, the FDA granted felzartamab Breakthrough Therapy Designation for the treatment of late AMR without T-cell mediated rejection in kidney transplant patients.
Rare Disease
SPINRAZA (nusinersen)
In January 2025, the FDA accepted the supplemental NDA and the EMA validated the application for a higher dose regimen of nusinersen for SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg-doses 14 days apart, and higher maintenance regimen, 28 mg, every four months, compared to the approved dose of SPINRAZA.
In September 2024, the company announced positive topline data from the Phase 2/3 DEVOTE study of nusinersen, which evaluated the safety and efficacy of a higher dose regimen of nusinersen in treatment-naive symptomatic infants with SMA.
In March 2024, the company announced new data from the Phase 4 RESPOND study for SPINRAZA. The study showed that neurofilament levels, an indicator of neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA. The reductions in biomarker complement previously reported RESPOND study efficacy results showing improved motor function in most participants treated with SPINRAZA after gene therapy.
SKYCLARYS
In September 2024 SKYCLARYS was approved by SWISSMEDIC for the treatment of FA in adults and adolescents aged 16 years and older.
In July 2024, the first pediatric patient was treated in the Phase 1 study of SKYCLARYS designed to identify the appropriate dose for the pediatric population living with FA.
QALSODY
In December 2024, the Japanese Ministry of Health, Labor and Welfare approved QALSODY in Japan.
In October 2024, QALSODY was approved in China by the NMPA under the conditional approval pathway for the treatment of adults with ALS associated with a mutation in the SOD1 gene.
In May 2024, the EC approved QALSODY in the E.U. for the treatment of adults with ALS associated with a mutation in the SOD1 gene. QALSODY is the first treatment approved in the E.U. to target a genetic cause of ALS.
Discontinued Programs and Studies
Sage Collaboration
zuranolone
In October 2024, the company and Sage agreed to not pursue further development of zuranolone for the potential treatment of MDD. This decision was based on the significant new investment and time the company expects would be needed to conduct the additional studies required to support approval of this indication.
BIIB124
In July 2024, the company and Sage announced that the Phase 2 KINETIC 2 dose-range study of BIIB124 did not meet its endpoints. Based on these results, the company discontinued its further development of BIIB124 and terminated the company’s rights under the collaboration and license agreement specific to BIIB124, effective February 17, 2025.
Samsung Bioepis 2019 Development and Commercialization Agreement
In October 2024, the company notified Samsung Bioepis of the company’s decision to terminate its 2019 Development and Commercialization Agreement (the DCA Agreement) solely within the U.S. and Canada. Biogen will transfer commercialization rights for BYOOVIZ and OPUVIZ in the U.S. and Canada back to Samsung Bioepis over a period of up to 18 months. During this transition period, the company will continue to commercialize BYOOVIZ. The termination does not impact the other markets in the DCA Agreement.
Ionis Collaboration
BIIB105
In May 2024, the company and Ionis announced that the Phase 1/2 ALSpire study of BIIB105, an investigational ASO for the potential treatment of ALS, did not meet its endpoints. Based on these results, the company discontinued its further development of BIIB105.
BIIB121
In May 2024, the company elected not to exercise its option to license and lead development of BIIB121, an ASO for the potential treatment of Angelman syndrome.
Merz Therapeutics (Previously Acorda Therapeutics, Inc.)
In January 2024, the company notified Acorda of the company’s decision to terminate the company’s collaboration and license agreement, effective January 1, 2025, whereby Acorda regained global commercialization rights to FAMPYRA. On April 1, 2024, Acorda filed for bankruptcy protection and announced its intention to sell substantially all of Acorda's assets to a third party. On July 10, 2024, Merz Therapeutics announced that its subsidiary Merz Pharmaceuticals LLC had completed the acquisition of FAMPYRA, and related assets from Acorda. The company is now working with Merz Therapeutics on the transition of global commercialization rights of FAMPYRA and the company expects to recognize minimal revenue in 2025.
BIIB143 (cemdomespib)
In early 2025, the company discontinued further development of BIIB143 (cemdomespib) for the treatment of diabetic neuropathic pain, as part of the company’s ongoing pipeline prioritization efforts.
Neurology
Multiple sclerosis
The company develops, manufactures and markets a number of products designed to treat patients with MS. MS is a progressive disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis, and in some cases, death. Patients with active RMS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted by flare-ups of the disease after which the patient may return to a lower baseline of functioning.
Neuropsychiatry
Neuropsychiatry includes ZURZUVAE for PPD, which became commercially available in the U.S. during the fourth quarter of 2023.
Rare Disease
Rare disease includes SPINRAZA for SMA, QALSODY for ALS, which became commercially available in the U.S. during the second quarter of 2023 and commercially available in the E.U. during the second quarter of 2024, and SKYCLARYS for FA, which was obtained as part of the company’s acquisition of Reata in September 2023. SKYCLARYS became commercially available in the U.S. during the second quarter of 2023 and the company began recognizing revenue from SKYCLARYS in the U.S. during the fourth quarter of 2023, subsequent to the company’s acquisition. SKYCLARYS was approved and became commercially available in the E.U. during the first quarter of 2024.
Biosimilars
The company commercializes a portfolio of biosimilars of advanced biologics, including: BENEPALI, an etanercept biosimilar referencing ENBREL; IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, which became commercially available in the U.S. during the second quarter of 2024 and approved in the E.U. during the second quarter of 2024. The company also has commercialization rights related to OPUVIZ, an aflibercept biosimilar referencing EYLEA, which was approved in the E.U. during the fourth quarter of 2024.
Genentech Relationships
The company has agreements with Genentech that entitle the company to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI, as well as the option to add other potential anti-CD20 therapies.
Patient Support and Access
The company interacts with patients, advocacy organizations and healthcare societies in order to gain insights into unmet needs. The insights gained from these engagements help the company supports patients with services, programs and applications that are designed to help patients lead fuller, healthier lives. Among other things, the company provides customer service and other related programs for the company’s products, such as disease and product specific websites, insurance research services, financial assistance programs and the facilitation of the procurement of the company’s marketed products.
The company is dedicated to helping patients obtain access to the company’s therapies. The company’s patient support representatives have access to a suite of financial assistance tools. With those tools, the company helps patients understand their insurance coverage, and if needed, help patients compare insurance options and programs. In the U.S., the company has established programs that provide co-pay assistance or free product for qualified uninsured or underinsured patients, based on specific eligibility criteria.
The company regularly reviews its pricing strategy and prioritize patient access to the company’s therapies. The company has a value-based contracting program designed to align the price of the company’s therapies to the value its therapies deliver to patients. The company also works with regulators, clinical researchers, ethicists, physicians and patient advocacy groups and communities, among others, to determine how best to address requests for access to the company’s investigational therapies in ways that are consistent with the company’s patient-focused values and compliant with regulatory standards and protocols.
Marketing and Distribution
Sales Force and Marketing
The company promotes its marketed products worldwide, including in the U.S., Europe and Japan, primarily through the company’s own sales forces and marketing groups. In some countries, particularly in areas where the company continues to expand into new geographic areas, the company partners with third parties.
RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI are marketed by the Roche Group and its sublicensees.
The company commercializes BENEPALI, IMRALDI, FLIXABI and BYOOVIZ pursuant to the company’s agreement with Samsung Bioepis in certain international markets.
The company focuses its sales and marketing efforts on physicians in private practice or at major medical centers. The company uses customary industry practices to market the company’s products and to educate physicians. This includes the company’s sales representatives calling on individual health care providers (in-person and virtually), advertisements, professional symposia, direct mail, digital marketing, point of care marketing, public relations and other methods. The company focuses on health care provider sales and marketing efforts on providers in both private practice and at major medical centers.
Distribution Arrangements
The company distributes its products in the U.S. principally through wholesale and specialty distributors of pharmaceutical products and specialty pharmacies, mail order specialty distributors or shipping service providers. In other countries, the distribution of the company’s products varies from country to country, including through wholesale distributors of pharmaceutical products and third-party distribution partners who are responsible for most marketing and distribution activities.
RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI are distributed by the Roche Group and its sublicensees.
The company distributes BENEPALI, IMRALDI and FLIXABI in certain countries in Europe; and has an option to acquire exclusive rights to distribute these products in China. The company also distributes BYOOVIZ in certain international markets and TOFIDENCE in the U.S.
The company’s product sales to two wholesale distributors each accounted for more than 10.0% of the company’s total revenue for the year ended December 31, 2024, and on a combined basis, accounted for approximately 39.3% of the company’s gross product revenue.
Trademarks
ADUHELM, AVONEX, BYOOVIZ, PLEGRIDY, QALSODY, RITUXAN, RITUXAN HYCELA, SKYCLARYS, SPINRAZA, TECFIDERA, TYSABRI and VUMERITY are registered trademarks of Biogen.
BENEPALI, FLIXABI, FUMADERM, IMRALDI, OPUVIZ and TOFIDENCE are trademarks of Biogen.
ACTEMRA, COLUMVI, ENBREL, EYLEA, FAMPYRA, GAZYVA, LEQEMBI, HUMIRA, LUCENTIS, LUNSUMIO, OCREVUS, REMICADE, ZURZUVAE and other trademarks are the property of their respective owners.
Business Relationships
As part of the company’s business strategy, the company establishes business relationships, including entering into licenses, joint ventures and collaborative arrangements with other companies, universities and medical research institutions, to assist in the clinical development and/or commercialization of certain of the company’s products and product candidates and to provide support for the company’s research programs. The company also evaluates opportunities for acquiring products or rights to products and technologies that are complementary to the company’s business from other companies, universities and medical research institutions.
Below is a brief description of certain business relationships and collaborations that expand the company’s pipeline and provide the company with certain rights to existing and potential new products and technologies.
Eisai
The company has a collaboration agreement with Eisai to jointly develop and commercialize LEQEMBI (lecanemab), an anti-amyloid antibody for the treatment of Alzheimer's disease. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. The company and Eisai co-promote LEQEMBI and share profits and losses equally. The company manufactures LEQEMBI drug substance and drug product and in March 2022 the company extended its supply agreement with Eisai related to LEQEMBI from five years to ten years for the manufacture of LEQEMBI drug substance.
Sage Therapeutics, Inc.
The company has a global collaboration and license agreement with Sage to jointly develop and commercialize ZURZUVAE (zuranolone) for the treatment of PPD.
Ionis
The company has several exclusive, worldwide option and collaboration agreements with Ionis to develop and commercialize antisense therapeutics, including SPINRAZA for the treatment of SMA and QALSODY for the treatment of ALS with SOD1 mutations, as well as other research programs for a broad range of neurological diseases. Under these agreements, the company has the option to license therapies arising out of these collaborations and will be responsible for their development and commercialization.
Genentech
The company has agreements with Genentech that entitle the company to certain business and financial rights with respect to RITUXAN, RITUXAN HYCELA, GAZYVA, OCREVUS, LUNSUMIO and COLUMVI, as well as the option to add other potential anti-CD20 therapies.
UCB
The company has a collaboration agreement with UCB to jointly develop and commercialize dapirolizumab pegol, an anti-CD40L pegylated Fab, for the potential treatment of SLE and other future agreed indications. If marketing approval is obtained, both companies will jointly commercialize dapirolizumab pegol and share profits and losses equally.
Denali
The company has a collaboration and license agreement with Denali to co-develop and co-commercialize Denali's small molecule inhibitors of LRRK2 for Parkinson's disease.
Samsung Bioepis
The company has an agreement with Samsung Bioepis to commercialize three anti-TNF biosimilar product candidates in certain countries in Europe. Under this agreement, the company is commercializing BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE.
The company has also secured the exclusive rights to commercialize BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain international markets, and OPUVIZ, an aflibercept biosimilar referencing EYLEA, which was approved in the E.U. during the fourth quarter of 2024. In addition to the company’s commercialization agreements with Samsung Bioepis, the company licenses certain of its proprietary technology to Samsung Bioepis in connection with Samsung Bioepis' development, manufacture and commercialization of its biosimilar products.
Regulatory
The company must adhere to current GMP and product-specific regulations enforced by regulatory agencies following product approval.
The company’s products are subject to discounted pricing when purchased by federal agencies via the FSS.
To maintain coverage of the company’s products under the Medicaid Drug Rebate Program and Medicare Part B, the company is required to extend significant discounts to certain covered entities that purchase products under Section 340B of the PHS pharmaceutical pricing program.
For all of the company’s products, the company must agree to charge a price that will not exceed the amount determined under statute (the ‘ceiling price’) when the company sells outpatient drugs to these covered entities.
The company is subject to various federal and foreign laws that govern the company’s international business practices with respect to payments to government officials. Those laws include the U.S. FCPA, which prohibits the U.S. companies and their representatives from paying, offering to pay, promising to pay or authorizing the payment of anything of value to any foreign government official, government staff member, political party or political candidate for the purpose of obtaining or retaining business or to otherwise obtain favorable treatment or influence a person working in an official capacity.
The laws to which the company is subject also include the U.K. Bribery Act 2010 (Bribery Act), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official and failing to have adequate procedures to prevent employees and other agents from giving bribes.
By local ordinance, the company is required to, among other things, comply with the NIH Guidelines in relation to the company’s facilities in RTP, North Carolina and are required to operate pursuant to certain permits.
History
Biogen Inc. was founded in 1978.
