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Sandoz Biosimilars

Goodwin

Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar

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On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv)....more

Venable LLP

Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval

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Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv).  The Complaint alleges infringement of 46 of...more

Venable LLP

EYLEA® Biosimilar Updates: Sandoz’s Enzeevu™ (aflibercept-abzv) FDA Approved, Regeneron Dismisses IPR Appeals

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On August 12, 2024, Sandoz announced the FDA approval of Enzeevu™ (aflibercept-abzv) as the fourth biosimilar of Regeneron’s EYLEA® (aflibercept).  Enzeevu™ was approved as provisionally interchangeable, subject to the...more

Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

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Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more

Venable LLP

The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.

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On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more

Goodwin

Sandoz to Acquire CIMERLI from Coherus for $170 Million

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On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. (“Coherus”) for an upfront cash purchase payment of USD 170 million. The...more

Morgan Lewis

Blockbuster Biologics Review | Issue 21

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Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Goodwin

HUMIRA (adalimumab) Biosimilar Launches

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​​​​​​​In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...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

Amgen Files BPCIA Complaint Against Sandoz Regarding Denosumab

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On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a...more

Goodwin

Sandoz Announces Approval for Biosimilar Hyrimoz® (adalimumab-adaz)

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On March 21, 2023, Sandoz, announced FDA approval of its citrate-free high-concentration formulation (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz) injection....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

Biosimilar Regulatory Approval Updates

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​​​​​​​Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more

Goodwin

Sandoz & Polpharma Announce FDA and EMA Acceptance of Applications for Natalizumab Biosimilar

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Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®. The proposed natalizumab...more

Goodwin

Sandoz’s High Concentration Adalimumab Biosimilar Application Accepted by EMA

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Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab). The indications covered in the application...more

Goodwin

Sandoz Announces New Global ‘Act4Biosimilars’ Initiative, to Improve Patient Access and Increase Adoption by At Least 30% in 30+...

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On May 31, 2022, Sandoz announced the launch of a new global initiative called “Act4Biosimilars” to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines...more

Goodwin

Sandoz submits BLA for proposed biosimilar trastuzumab to the FDA

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Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA. According to the press release, the biosimilar trastuzumab was...more

Smart & Biggar

Supreme Court of Canada denies Amgen leave to appeal decision invalidating its filgrastim patent

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As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...more

Goodwin

International Biosimilar Launches: Ujvira and PrInclunox®

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On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar.  The drug is a trastuzumab emtansine biosimilar - using Genentech’s Kadcyla as the reference product - that will be marketed...more

Goodwin

Sandoz to begin Phase III trial of aflibercept biosimilar

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On May 3, 2021, Sandoz announced that it will begin enrolling patients in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study for its proposed biosimilar to Regeneron’s EYLEA (aflibercept) product. EYLEA is...more

Patterson Belknap Webb & Tyler LLP

Sandoz Petitions the Supreme Court for Review of Enbrel® Patent License

The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the...more

Goodwin

Recent Adalimumab Biosimilar Updates

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On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all...more

Fish & Richardson

Biosimilars 2020 Year in Review

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Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Refuses to Reconsider Its Panel Decision Finding No Common Ownership of Immunex’s Enbrel Patent

Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®... ...more

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