In a 104-page ruling, U.S. District Judge Mark L. Wolf granted summary judgment in favor of Celltrion and Hospira, finding that a doctrine of equivalents claim made by Janssen Biotech (“Janssen”) with respect to a Remicide®-related patent would ensnare the prior art.

Janssen makes Remicade®, a biologic drug whose active ingredient is the monoclonal

On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States.  According to Merck’s press release, Renflexis® “will be introduced in the U.S. [at] . . . a 35 percent discount to the current list price” of the reference product.  Renflexis® is the second FDA-approved

Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have been several developments, including those that occurred after the Supreme Court’s recent Amgen v. Sandoz decision.

The last major development we previously discussed was a motion for a preliminary injunction filed by Amgen seeking “to

This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”), Celltrion Healthcare Co. and Celltrion, Inc. (“Celltrion”), and Hospira Inc. (“Hospira”).

Briefly, when we last addressed this case, the litigation had already been narrowed to one patent, U.S. Patent No. 7,598,083 (“the ’083 patent”).  Further, there were

Introduction

The Amgen, Inc. and Amgen Manufacturing, Limited (“Amgen”) litigation against Hospira, Inc. (“Hospira”), filed in September 2015, was one of the earliest cases filed under the Biologics Price Competition and Innovation Act (“BPCIA”).  The case involves Hospira’s proposed biosimilar to Amgen’s Epogen®/Procrit® (epoetin alfa).  The procedural posture is somewhat complicated, as

Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s Epogen®/Procrit® for approval across all indications after a public meeting held on May 25, 2017.  The meeting materials are available from the FDA’s website here.

The history of this application is interesting.  The original biologics application

Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson,   (“Janssen” or “Plaintiff”) filed a Complaint in the United States District Court for the District of New Jersey against Samsung Bioepis Co., Ltd. (“Samsung Bioepis” or “Defendant”),  a joint venture between Samsung Biologics and Biogen.  The patent infringement litigation relates to Samsung Bioepis’s

FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017.  Renflexis® is the fifth biosimilar approved by the FDA and the second infliximab biosimilar to Janssen’s Remicade®.  Infliximab is an Anti-Tumor Necrosis Factor (Anti-TNF) monoclonal antibody approved in the U.S. for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and

Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and only two of those products are commercially available to patients in the United States – Sandoz’s Zarxio® (a filgrastim biosimilar to Amgen’s Neupogen®) and Celltrion and Hospira’s Inflectra® (an infliximab biosimilar to