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Interferon beta-1a
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== Society and culture == ===Brand names=== ====Avonex==== Avonex was approved in the US in 1996,<ref name="Approval of Avonex">{{cite news | title=F.D.A. Approves a Biogen Drug for Treating Multiple Sclerosis | website=[[The New York Times]] | date=8 May 1996 | url=https://www.nytimes.com/1996/05/18/business/fda-approves-a-biogen-drug-for-treating-multiple-sclerosis.html | access-date=16 January 2021 | archive-date=22 January 2021 | archive-url=https://web.archive.org/web/20210122104645/https://www.nytimes.com/1996/05/18/business/fda-approves-a-biogen-drug-for-treating-multiple-sclerosis.html | url-status=live }}</ref> and in the European Union in 1997, and is registered in more than 80 countries worldwide.{{cn|date=October 2020}} It is the leading MS therapy in the US, with around 40% of the overall market, and in the European Union, with around 30% of the overall market.{{citation needed|date=April 2015}} It is produced by the [[Biogen]] [[biotechnology]] company, originally under competition protection in the US under the [[Orphan Drug Act]]. Avonex is sold in three formulations, a lyophilized powder requiring reconstitution, a pre-mixed liquid syringe kit, and a pen; it is administered via [[intramuscular injection]].<ref name="Avonex FDA label">{{cite web | title=Avonex- interferon beta-1a kit Avonex Pen- interferon beta-1a injection, solution Avonex- interferon beta-1a injection, solution | website=DailyMed | date=30 March 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1 | access-date=1 October 2020 | archive-date=25 March 2021 | archive-url=https://web.archive.org/web/20210325060926/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d70a39cc-de15-4c12-a1ec-8063b69ea0e1 | url-status=live }}</ref> ====Rebif==== Rebif is a disease-modifying drug (DMD) used to treat multiple sclerosis in cases of clinically isolated syndromes as well as relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. It is co-marketed by [[Merck Serono]] and [[Pfizer]] in the US under an exception to the [[Orphan Drug Act]]. {{cn|date=October 2020}} It was approved in the European Union in 1998, and in the US in 2002; it has since been approved in more than 90 countries worldwide including Canada and Australia.{{cn|date=October 2020}} EMD Serono has had sole rights to Rebif in the US since January 2016.<ref>{{Cite web|url=https://www.emdgroup.com/en/expertise/neurology-and-immunology.html|title=Neurology & Immunology|website=EMD Group|access-date=2021-08-08|archive-date=2024-04-07|archive-url=https://web.archive.org/web/20240407080938/https://www.emdgroup.com/en/expertise/neurology-and-immunology.html|url-status=live}}</ref><ref>{{Cite press release|url=https://www.prnewswire.com/news-releases/emd-serono-takes-on-exclusive-promotion-of-rebif-interferon-beta-1a-in-the-us-300205988.html|title=EMD Serono Takes on Exclusive Promotion of Rebif (interferon beta-1a) in the US|publisher=EMD Serono|via=PR Newswire|access-date=2021-08-08|archive-date=2023-03-29|archive-url=https://web.archive.org/web/20230329045259/https://www.prnewswire.com/news-releases/emd-serono-takes-on-exclusive-promotion-of-rebif-interferon-beta-1a-in-the-us-300205988.html|url-status=live}}</ref> Rebif is administered via [[subcutaneous injection]].<ref name="Rebif FDA label">{{cite web | title=Rebif- interferon beta-1a kit Rebif Rebidose- interferon beta-1a kit Rebif- interferon beta-1a injection, solution Rebif- interferon beta-1a injection, solution Rebif Rebidose- interferon beta-1a injection, solution | website=DailyMed | date=5 June 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f | access-date=1 October 2020 | archive-date=24 March 2021 | archive-url=https://web.archive.org/web/20210324222529/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f | url-status=live }}</ref> ====Cinnovex==== Cinnovex is the brand name of recombinant Interferon beta-1a, which is manufactured as biosimilar/biogeneric in [[Iran]]. It is produced in a lyophilized form and sold with [[distilled water]] for injection. Cinnovex was developed at the [[Fraunhofer Society]] in collaboration with [[CinnaGen]], and is the first therapeutic protein from a [[Fraunhofer Society|Fraunhofer laboratory]] to be approved as biogeneric / biosimilar medicine. There are several clinical studies to prove the similarity of CinnoVex and Avonex.<ref>{{cite journal | vauthors = Nafissi S, Azimi A, Amini-Harandi A, Salami S, shahkarami MA, Heshmat R | title = Comparing efficacy and side effects of a weekly intramuscular biogeneric/biosimilar interferon beta-1a with Avonex in relapsing remitting multiple sclerosis: a double blind randomized clinical trial | journal = Clinical Neurology and Neurosurgery | volume = 114 | issue = 7 | pages = 986β989 | date = September 2012 | pmid = 22429566 | doi = 10.1016/j.clineuro.2012.02.039 | s2cid = 9236986 }}</ref> A more water-soluble variant is currently being investigated by the Vakzine Projekt Management (VPM) GmbH in Braunschweig, Germany. ====Plegridy==== {{Main|Peginterferon beta-1a}} {{See also|Multiple_sclerosis_research#Phase_III}} Plegridy is a brand name of a [[pegylated]] form of Interferon beta-1a. Plegridy's advantage is it only needs injecting once every two weeks.<ref name="Plegridy FDA label">{{cite web | title=Plegridy- peginterferon beta-1a kit Plegridy Pen- peginterferon beta-1a kit Plegridy- peginterferon beta-1a injection, solution | website=DailyMed | date=19 July 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08f0ea03-4e6d-195d-aef4-886e32befa95 | access-date=30 March 2020 | archive-date=26 June 2020 | archive-url=https://web.archive.org/web/20200626040916/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08f0ea03-4e6d-195d-aef4-886e32befa95 | url-status=live }}</ref> ====Betaferon (interferon beta-1b)==== Closely related to interferon beta-1a is [[interferon beta-1b]], which is also indicated for MS, but is formulated with a different dose and administered with a different frequency. Each drug has a different safety/efficacy profile.<ref>{{cite journal | vauthors = Nikfar S, Rahimi R, Abdollahi M | title = A meta-analysis of the efficacy and tolerability of interferon-Ξ² in multiple sclerosis, overall and by drug and disease type | journal = Clinical Therapeutics | volume = 32 | issue = 11 | pages = 1871β1888 | date = October 2010 | pmid = 21095482 | doi = 10.1016/j.clinthera.2010.10.006 }}</ref> Interferon beta-1b is marketed only by [[Bayer]] in the US as Betaseron, and outside the US as Betaferon. ===Economics=== In the United States, {{as of|2015|lc=yes}}, the cost is between US$1,284 and US$1,386 per 30 mcg vial.<ref>{{cite news|vauthors=Langreth R|title=Decoding Big Pharma's Secret Drug Pricing Practices|url=https://www.bloomberg.com/graphics/2016-drug-prices/|access-date=15 July 2016|publisher=Bloomberg|date=June 29, 2016|archive-date=13 July 2016|archive-url=https://web.archive.org/web/20160713133019/http://www.bloomberg.com/graphics/2016-drug-prices/|url-status=live}}</ref> As of 2020, the National Average Drug Acquisition Cost (NADAC) in the United States for Avonex was $6,872.94 for a 30 mcg kit.<ref>{{Cite web|url=https://data.medicaid.gov/Drug-Pricing-and-Payment/NADAC-as-of-2020-02-12/2ghv-q5xv|title=NADAC as of 2020-02-12 | work = Centers for Medicare and Medicaid Services|language=en|access-date=2020-02-18|archive-date=2020-02-18|archive-url=https://web.archive.org/web/20200218171241/https://data.medicaid.gov/Drug-Pricing-and-Payment/NADAC-as-of-2020-02-12/2ghv-q5xv|url-status=dead}}</ref> Avonex and Rebif are on the top ten best-selling multiple sclerosis drugs of 2013.<ref>{{Cite web|url=https://www.fiercepharma.com/special-report/top-10-best-selling-multiple-sclerosis-drugs-of-2013|title=The top 10 best-selling multiple sclerosis drugs of 2013|website=FiercePharma|date=9 September 2014|access-date=8 August 2021|archive-date=26 February 2024|archive-url=https://web.archive.org/web/20240226115050/https://www.fiercepharma.com/special-report/top-10-best-selling-multiple-sclerosis-drugs-of-2013|url-status=live}}</ref> It is an example of a [[specialty drugs|specialty drug]] that would only be available through a [[specialty pharmacy]]. This is because it requires a refrigerated chain of distribution and costs $17,000 a year.<ref name="ncbi_2013">{{cite journal | vauthors = Gleason PP, Alexander GC, Starner CI, Ritter ST, Van Houten HK, Gunderson BW, Shah ND | title = Health plan utilization and costs of specialty drugs within 4 chronic conditions | journal = Journal of Managed Care Pharmacy | volume = 19 | issue = 7 | pages = 542β548 | date = September 2013 | pmid = 23964615 | doi = 10.18553/jmcp.2013.19.7.542 | pmc = 10437312 }}</ref> {| class="wikitable" |- ! No. !! 2013 Global Sales !! [[International Nonproprietary Name|INN]] !! Brand names !! Companies |- | 1 || $4.33 billion || [[Glatiramer acetate]] || Copaxone || Teva |- | 2 || $3.00 billion || Interferon beta 1a || Avonex || Biogen Idec |- | 3 || $2.51 billion || Interferon beta 1a || Rebif || Merck KGaA |- | 4 || $1.93 billion || [[Fingolimod]] || Gilenya || Novartis |- | 5 || $1.41 billion || [[Natalizumab]] || Tysabri || Biogen Idec |- | 6 || $1.38 billion || [[Interferon beta 1b]] || Betaseron/Betaferon || Bayer HealthCare |- | 7 || $876 million || [[Dimethyl fumarate]] || Tecfidera || Biogen Idec |- | 8 || $303 million || [[4-Aminopyridine]] || Ampyra || [[Acorda Therapeutics]] |- | 9 || $250 million || [[Adrenocorticotropic hormone]] || H.P. Acthar Gel || Questcor Pharmaceuticals |- | 10 || $221 million || [[Teriflunomide]] || Aubagio || Sanofi |}
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