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Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Goodwin

Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

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An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two...more

Goodwin

Federal Circuit Affirms Biosimilar-Related IPR Appeals; Bevacizumab Injunction Appeal Progresses

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Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more

Herbert Smith Freehills Kramer

Biosimilars in 2020: What’s Ahead

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The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

Herbert Smith Freehills Kramer on

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

Goodwin

Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

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Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more

Goodwin

Q1 2018 Earnings Roundup: Biosimilars Update

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Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

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With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Goodwin

FDA Advisory Panels Considering Approvals of Two Biosimilars This Week

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An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s...more

Goodwin

FDA: Amgen’s Biosimilar “Highly Similar” to Abbvie’s Humira

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A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to...more

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