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Biogen Idec

Goodwin

Biogen’s TOFIDENCE (tocilizumab) Approved in the EU

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​​​​​​​This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA.  TOFIDENCE was approved by the FDA in September 2023....more

Goodwin

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

Goodwin

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

Goodwin

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

Goodwin

Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents

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This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221)....more

Goodwin

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

Goodwin

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

Goodwin

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

Sheppard Mullin Richter & Hampton LLP

Biogen Settlement Summary

On Monday September 26, the Department of Justice announced a settlement resolving a lawsuit filed by former employee Michael Bawduniak (the “Plaintiff”) against Biogen Inc. (the “Company”) under the qui tam provisions of the...more

Goodwin

Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab

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​​​​​​​On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen’s complaint is filed under seal.  Based on the list of 28 asserted patents, the case appears to...more

Dorsey & Whitney LLP

A Hefty Speaking Fee: Biogen Inc. Agrees to Settle False Claims Act Suit In Violation of Anti-Kickback Statute for $900 Million

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​​​​​​​On July 20, 2022, Biogen Inc. (“Biogen”) disclosed in a quarterly earnings report that it had agreed to pay $900 million to resolve a qui tam claim by a former employee that the company had violated the False Claims...more

Goodwin

Supreme Court Cert Petitions on Skinny Label Inducement and Written Description Issues

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On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK...more

Goodwin

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

Goodwin

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

Goodwin

Samsung Biologics Completes Full Acquisition of Samsung Bioepis

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In January 2022, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics. On April 20, 2022, Samsung Biologics and Biogen announced that...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

Kilpatrick

Drug Discovery Catch-22: A Healthy Dose of Written Description

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To satisfy the written description requirement under 35 U.S.C. 112, a patent specification must describe the claimed invention in such sufficient detail that a person of skilled in the art (POSA) can reasonably conclude that...more

Goodwin

Biogen Sells Bioepis Stake for $2.3 Billion to Samsung Biologics

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Last week, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics for an aggregate consideration of up to $2.3 billion.  According to a...more

Knobbe Martens

Federal Circuit Review - November 2021

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Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more

Knobbe Martens

Written Description: What Is the Proper “Dosage” to Satisfy This Requirement?

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BIOGEN INTERNATIONAL GMBH V. MYLAN PHARMACEUTICALS INC. Before O’Malley, Reyna, and Hughes. Appeal from the United States District Court for the Northern District of West Virginia. Summary: A specification may not...more

Goodwin

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

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Market News

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Recent notable industry transactions. Royal Philips announced that it has agreed to acquire Capsule Technologies, Inc., a provider of medical device integration and data technologies for hospitals and healthcare...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 9

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In Washington: The Senate passed a one-week stopgap bill on Friday, hours ahead of a government shutdown deadline. The bill passed on a voice vote and moved the funding deadline to December 18. The continuing resolution...more

Robins Kaplan LLP

Biogen Int'l GmbH v. Banner Life Scis. LLC

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BECAUSE DEFENDANT’S NDA PRODUCT DOES NOT INCLUDE ANY SALT OR ESTER OF THE ACTIVE INGREDIENT IN PLAINTIFF’S REFERENCE DRUG, PATENT TERM EXTENSION DID NOT APPLY AND JUDGMENT OF NON-INFRINGEMENT WAS AFFIRMED. Case...more

Seyfarth Shaw LLP

California Supreme Court Clarifies Pleading Requirements for Claims of Tortious Interference with At-Will Contracts

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Called upon by the Ninth Circuit in Ixchel Pharma, LLC v. Biogen, Inc. to answer two key questions concerning the validity of a settlement provision requiring a party’s termination of a collaboration agreement with a...more

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