News & Analysis as of

Amgen Pharmaceutical Industry

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

Industry Perspectives On The Biosimilar Patent Dance

by Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

FDA Advisory Committee to Hold Public Meetings on Amgen’s Proposed Bevacizumab Biosimilar and Mylan’s Proposed Trastuzumab...

by Goodwin on

The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee...more

Amgen Seeks Discovery Regarding AbbVie’s Patent Dance with Other Biosimilar Applicants

by Goodwin on

In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants...more

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...more

Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

by Goodwin on

As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit®...more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

by Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Apotex Citizen Petition Seeks to Heighten Regulatory Requirements for Biosimilar Competition

by Goodwin on

Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that...more

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc.

On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be...more

Further Recent Biologics Applications

by Goodwin on

We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental BLA to the FDA and an...more

Amgen Obtains FDA Priority Review for BLINCYTO (blinatumomab)

by Goodwin on

Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell...more

Sanofi and Regeneron Take Aim on Amgen IL-4 Receptor Patent

by Goodwin on

This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S....more

Delaware District Court Dismisses Genentech v. Amgen

by Goodwin on

As we previously reported, yesterday Judge Sleet, United States District Court for the District of Delaware, heard arguments on Amgen’s motion to dismiss in Genentech v. Sandoz. The court orally granted Amgen’s motion under...more

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