Editing Biogen (section)

== Pipeline ==

Biogen focused its R&D efforts on the discovery and development of treatments for patients with high unmet medical needs in the areas of neurology, hematology, and immunology.{{citation needed|date=August 2021}}

Investigational MS medicines:
* Daclizumab High-Yield Process (DAC HYP): is being developed as a potential once-monthly subcutaneous injection in the treatment of relapsing-remitting multiple sclerosis (RRMS). DAC HYP is being developed in collaboration with [[Abbvie]], Inc. In June 2014, the companies announced positive top-line results from the Phase III DECIDE clinical trial, where DAC HYP demonstrated superiority over interferon beta-1a in annualized relapse rate.<ref>{{cite web
   |url        = http://www.fiercebiotech.com/story/once-monthly-ms-drug-biogen-idec-abbvie-clears-phase-iii-hurdle/2014-06-16
   |title      = Once-monthly MS drug from Biogen Idec, AbbVie clears Phase III hurdle
   |publisher  = Fierce Biotech
   |access-date=2013-04-08
}}</ref>
* Anti-LINGO-1 (BIIB033) ([[Opicinumab]]): is the first candidate being investigated for its potential to remyelinate and repair neurons damaged by MS, currently in Phase 2 trials.<ref>{{cite web
   |url        = http://multiple-sclerosis-research.blogspot.com/2013/05/lingo-promising-remyelination-target-in.html
   |title      = Lingo: a promising remyelination target in MS
   |publisher  = Multiple Sclerosis Research
   |access-date=2014-06-16
}}</ref>

Biogen has several candidates in Phase 1 and 2 clinical trials in neurodegenerative and immunological diseases including MS, neuropathic pain, spinal muscular atrophy and lupus nephritis:
* Phase 2a: anti-LINGO-1 molecule ([[Opicinumab]]) in acute optic neuritis
* Phase 2b: anti-TWEAK monoclonal antibody in lupus nephritis
* Phase 2a: STX-100 in patients with idiopathic pulmonary fibrosis
* Phase 2: Neublastin for neuropathic pain in 2013
* Phase 1/2: BIIB067 (ISIS-SOD1<sub>Rx</sub>) for [[amyotrophic lateral sclerosis]], in collaboration with Ionis

Biogen also has several development agreements in place with Ionis Pharmaceuticals to collaborate to leverage antisense technology in advancing the treatment of neurological disorders.<ref name="auto3">{{cite web
   |url        = http://www.fiercebiotech.com/special-reports/top-20-biotech-licensing-deals-h1-2012/isis-pharmaceuticals-and-biogen-idec
   |title      = Isis Pharmaceuticals and Biogen Idec
   |publisher  = Fierce Biotech
   }}</ref>

In February 2012, Biogen formalized a joint venture with [[Samsung]], creating Samsung Bioepis. This joint venture brings Biogen's expertise and capabilities in protein engineering, cell line development, and recombinant biologics manufacturing to position the joint venture so Biogen can participate in the emerging market for biosimilars.<ref>{{cite web
   |url        = http://www.businessweek.com/news/2013-11-12/biogen-sees-eloctate-fda-delay-pushing-market-entry-to-mid-2014
   |archive-url = https://archive.today/20140726132515/http://www.businessweek.com/news/2013-11-12/biogen-sees-eloctate-fda-delay-pushing-market-entry-to-mid-2014
   |url-status = dead
   |archive-date = July 26, 2014
   |title      = Biogen Sees Eloctate FDA Delay Pushing Marketing to Mid-2014
   |publisher  = BusinessWeek
   |access-date=2013-12-11
}}</ref>

In early 2014, Biogen entered into an agreement with Eisai, Inc., to jointly develop and commercialize two of their candidates for Alzheimer's disease, which have the potential to reduce Aβ plaques that form in the brains of patients, as well as to slow the formation of new plaques, potentially improving symptoms and suppressing disease progression.<ref name="auto3" />

Biogen also has since 2015 an agreement with AGTC to develop gene therapy for several genetic diseases, including X-linked retinoschisis (XLRS) and X-linked Retinitis pigmentosa (XLRP) ophthalmologic diseases. To this aim, Biogen paid AGTC $124 million, including an equity investment of $30 million, and up to 1,1 billion in future milestones.<ref>{{cite web|title=Biogen Offers Up To $1 Billion for AGTC's Ophthalmology Gene Therapy|work= Xconomy Boston|author= David Holley|date= July 2, 2015|url= http://www.xconomy.com/boston/2015/07/02/biogen-offers-up-to-1-billion-for-agtcs-ophthalmology-gene-therapy/}}</ref>

In March 2019, Biogen halted Phase 3 trials of Alzheimer's disease drug Aducanumab after "an independent group's analysis show[ed] that the trials were unlikely to 'meet their primary endpoint.'"<ref>{{cite news |last1=Li |first1=Yun |title=Biogen shares plunge nearly 30% after ending trial for Alzheimer's drug Aducanumab |url=https://www.cnbc.com/2019/03/21/biogen-shares-plunge-more-than-25percent-after-ending-trial-for-alzheimers-drug-aducanumab.html |publisher=CNBC |date=21 March 2019}}</ref> However, in October 2019 they reversed their plans and said that they would be pursuing US FDA approval for Aducanumab. The reversal came after Biogen said a new analysis of a larger patient pool showed promising results.<ref name=":0" /> In July 2020, Biogen completed submission of a [[Biologics license application]]  (BLA) to the FDA for review, and requested accelerated review.<ref>{{Cite web|title=Biogen submitted its Alzheimer's drug for approval. Now what?|url=https://www.biopharmadive.com/news/biogen-alzheimers-aducanumab-submit-fda/581233/|access-date=2020-07-29|website=BioPharma Dive|language=en-US}}</ref> However, an advisory panel for the FDA voted against approval of this drug.<ref>Pam Belluck: [https://www.nytimes.com/2020/11/06/health/aducanumab-alzheimers-drug-fda-panel.html?smid=tw-share ''F.D.A. Panel Declines to Endorse Controversial Alzheimer’s Drug.''] New York Times, November 6, 2020. Retrieved January 20, 2021.</ref> On June 7, 2021, the FDA granted approval of Aducanumab for the treatment of Alzheimer's disease. Aducanumab was approved using the accelerated approval pathway, and Biogen will be required to conduct a post-approval clinical trial to verify clinical benefit for continued approval.<ref>{{Cite press release|title=FDA Grants Accelerated Approval for Alzheimer's Drug|date=7 Jun 2021|publisher=US Food & Drug Administration|url=https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug|archive-url=https://web.archive.org/web/20210607153129/https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug|url-status=dead|archive-date=June 7, 2021|access-date=7 Jun 2021}}</ref>