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Biogen Idec Biosimilars

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Biogen Announces FDA Approval of TOFIDENCE, a Tocilizumab Biosimilar Referencing ACTEMRA

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​​​​​​​On September 29, 2023, Biogen announced the FDA approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation which is the first tocilizumab biosimilar approved by the FDA in the United States.  TOFIDENCE is...more

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Court Denies Motion for Preliminary Injunction in Biogen v. Sandoz Natalizumab BPCIA Litigation

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As we previously reported, Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. On October 19, 2022, Biogen filed a Motion for Preliminary Injunction and Motion...more

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Biogen Seeks Preliminary Injunction in Natilizumab BPCIA Litigation - Hearing Scheduled for May 17

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In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis biosimilar of TYSABRI...more

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FDA Accepts Biogen’s aBLA for Tocilizumab

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On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen’s tocilizumab biosimilar candidate.  BIIB800 references Genetech’s ACTEMRA product, which is an anti-interleukin-6...more

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Biogen Seeks a Preliminary Injunction in Natalizumab BPCIA Case Against Sandoz

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​​​​​​​Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint...more

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Biogen Announces EMA Acceptance of Tocilizumab Biosimilar Application

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​​​​​​​Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA...more

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Biogen and Samsung Bioepis launch BYOOVIZ (ranibizumab-nuna)

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On June 2, 2022, Biogen Inc. and Samsung Bioepis Co., Ltd. announced  that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing Genentech’s LUCENTIS®, will be available in the United States on July 1, 2022. BYOOVIZ™ is the...more

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Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

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Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more

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Biogen and Xbrane Enter into Worldwide Commercialization and License Agreement for Certolizumab Pegol Biosimilar

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On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA. Under the...more

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Biogen/Samsung Approval of BYOOVIZ™

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Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ™ (ranibizumab-nuna) was approved by FDA.  BYOOVIZ™ is a biosimilar to LUCENTIS®, which is indicated for the treatment of...more

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Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

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Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

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Samsung Bioepis and Biogen Announces Pooled Analysis of Three Anti-TNF Biosimilars

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Yesterday, Samsung Bioepis and Biogen announced pooled analysis results that will be presented this week at the 2018 Annual European Congress of Rheumatology (EULAR). Data from three separate Phase III randomized,...more

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IPR Updates

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Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more

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CT-P10 Shows Equivalent Pharmacokinetic and Comparable Efficacy with Rituximab

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Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid...more

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Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

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At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from...more

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A Global Phase III Trial for Avastin Biosimilar Has Begun

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Samsung Bioepis – the joint venture between Samsung and Biogen Idec – has started a phase III clinical trial for a biosimilar version of Roche’s cancer drug Avastin (bevacizumab). Bevacizumab slows the growth of new blood...more

Patterson Belknap Webb & Tyler LLP

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

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