News & Analysis as of

Pfizer Amgen Pharmaceutical Industry

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Goodwin

Antitrust & Competition Life Sciences Year in Review 2023

Goodwin on

Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q1 2023

Goodwin on

Our prior updates covered how FTC enforcement activity largely proceeded “as usual” during 2022 in the life sciences industry, with large pharmaceutical players buying or licensing promising, but still risky, assets from...more

Goodwin

Antitrust & Competition Life Sciences 2022 Year In Review

Goodwin on

M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more

Goodwin

Amgen and Pfizer Developing More Interchangeable Biosimilars

Goodwin on

In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars.  Amgen announced that patients are currently being enrolled in Phase 3 studies...more

Goodwin

Motion to Dismiss Denied in Amgen v. Hospira BPCIA

Goodwin on

At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties.  We previously reported back in February 2020 that Amgen sued Pfizer and its...more

Goodwin

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2020

Goodwin on

As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more

Goodwin

Delaware Court Denies Motion to Consolidate Filgrastim Cases Against Pfizer

Goodwin on

The U.S. District Court for the District of Delaware has denied Amgen’s motion to consolidate a recently filed action against Pfizer and its affiliate Hospira relating to Hospira’s filgrastim biosimilar with an ongoing...more

Goodwin

Amgen Sues Pfizer and Hospira for Patent Infringement related to Hospira’s Filgrastim Biosimilar

Goodwin on

Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar. The action is related to newly granted U.S. Patent No. 10,577,392, which is...more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - March 2020

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more

Goodwin

Amgen Sues Pfizer Over Proposed Neulasta Biosimilar

Goodwin on

On February 11, 2020 Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing the incidence of infection in...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

Goodwin on

This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

Goodwin on

On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Smart & Biggar

Amended PMNOC Regulations: Second Anniversary Update

Smart & Biggar on

September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more

Goodwin

Pipeline Updates: Pfizer, Amgen, and Allergan

Goodwin on

Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development. According RAPs, Pfizer’s Director of Global Media...more

Goodwin

Biosimilar-Related Patent Litigation Updates

Goodwin on

Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more

Goodwin

BPCIA Litigation Updates: Bevacizumab, Trastuzumab, Filgrastim

Goodwin on

More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts. Below are some highlights of activity in some of those cases from this month....more

Goodwin

New BPCIA Complaint: Amgen Sues Pfizer over Proposed Filgrastim Biosimilar

Goodwin on

Today, Amgen filed a complaint in the District of Delaware against Hospira and its parent Pfizer alleging infringement of U.S. Patent No. 9,643,997 based on Hospira’s filing of an aBLA seeking FDA-approval to engage in the...more

Goodwin

Q1 2018 Earnings Roundup: Biosimilars Update

Goodwin on

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more

Goodwin

Biosimilar Litigation Updates: Joint Status Reports

Goodwin on

Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report. Among other things, the parties offered their competing proposals for discovery deadlines. ...more

Goodwin

Year in Review: The Top-Five U.S. Market Developments of 2017

Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Patterson Belknap Webb & Tyler LLP

US Biosimilar Approvals Soar in 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more

Patterson Belknap Webb & Tyler LLP

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Goodwin

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

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

32 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide