News & Analysis as of

Amgen Pharmaceutical Industry

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

FDA Approves Amgen’s Biosimilar of Avastin®

by Goodwin on

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of...more

Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

by Goodwin on

At the European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of...more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Amgen v. Coherus: Coherus Files Reply in Support of Motion to Stay

by Goodwin on

As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on...more

Federal Circuit Confirms Innovators Must Sue Blind When Biosimilar Makers Withhold Information

On August 10, 2017, the Federal Circuit issued its decision in Amgen v. Hospira. It dismissed Amgen’s interlocutory appeal from a discovery order on jurisdictional grounds and denied a writ of mandamus ordering the district...more

Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)

In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more

Amgen’s Opposes Coherus’s Motion to Stay in Pegfilgrastim Case

by Goodwin on

In response to Coherus’s motion to stay discovery in Amgen v. Coherus, Amgen filed an answering brief yesterday opposing this motion. Amgen claimed that any delay in the proceedings would “unduly prejudice Amgen and present a...more

Coherus Update on Biosimilar Pipeline

by Goodwin on

Coherus announced completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a...more

Q2 Earnings Round-Up

by Goodwin on

Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. ..Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and...more

Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

by Goodwin on

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more

Update: Coherus’ Motion to Stay Discovery in Amgen v. Coherus

by Goodwin on

Earlier this week Coherus filed a motion to stay the BPICA litigation brought by Amgen in the District of Delaware, arguing that in light of the FDA’s complete response letter delaying the launch of Coherus’ pegfilgrastim...more

Coherus Requests Stay Of Discovery in Amgen v. Coherus

by Goodwin on

We previously reported, Amgen filed a BPCIA suit against Coherus Biosciences, Inc., relating to its aBLA for its pegfilgrastim (Neulasta®) biosimilar. In response, Coherus filed a motion to dismiss the suit arguing that...more

Amgen Withdraws Its Motion For Preliminary Injunction Against Hospira

by Goodwin on

On July 12, 2017, Amgen filed a Notice of Withdrawal of its Motion for Preliminary Injunction. As we previously reported, Amgen had filed an amended opening brief in support of its motion for preliminary injunction because of...more

First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

Sandoz Inc. v Amgen Inc.

by Hodgson Russ LLP on

Artificial patent infringement occurs when certain types of approval applications are submitted to the U.S. Food And Drug Administration (the “FDA”). The U.S. Supreme Court recently considered a situation in which an...more

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

ITC Section 337 – Quarterly Highlights

by Hogan Lovells on

SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more

Supreme Court Affords Greater Leeway to Biosimilars in the 'Patent Dance'

by Pepper Hamilton LLP on

In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with reference product sponsors — a process known as the “patent dance.” Since...more

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

by Thompson Coburn LLP on

In a unanimous opinion, the United States Supreme Court again reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting the meaning of key provisions of the Biologics Price Competition and Innovation Act of...more

Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can...

On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...more

Sandoz Inc. v. Amgen Inc. (2017)

On June 12, 2017, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of...more

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