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Sandoz FDA Approval Patent Litigation

Venable LLP

Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation...

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On February 28, 2025, the FDA approved Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) as the third company to receive FDA approval of biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more

Goodwin

Year in Review: Top Legal Developments of 2024

Goodwin on

​​​​​​​As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more

Venable LLP

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

Venable LLP on

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

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

Venable LLP on

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

Mintz - Intellectual Property Viewpoints

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more

Goodwin

Sandoz’s Enbrel Biosimilar on Hold Until Patent Case Resolved

Goodwin on

As we reported last August, the FDA has already approved Erelzi®, Sandoz’s biosimilar version of Amgen’s psoriasis drug Enbrel.® However, the head of generics at Novartis (Sandoz’s parent) told Reuters this week that their...more

Womble Bond Dickinson

Courts Answer Key Questions Over the Reach of the BPCIA

Womble Bond Dickinson on

Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

Goodwin

Amgen v. Sandoz: Reply Briefs Submitted to Supreme Court

Goodwin on

As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing”...more

Foley & Lardner LLP

FDA Panel Shows Strong Support for a Remicade Biosimilar

Foley & Lardner LLP on

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

Foley & Lardner LLP

No Rehearing Of Biosimilar Patent Dance Decision

Foley & Lardner LLP on

The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies En Banc Petition in Amgen v. Sandoz

The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)

Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- En Banc Rehearing Petitions Filed

On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more

McDonnell Boehnen Hulbert & Berghoff LLP

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

Mintz - ML Strategies

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

Mintz - ML Strategies on

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Interprets Biosimilars Law in Amgen v. Sandoz

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

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