News & Analysis as of

UPDATE: Mylan Files Amicus Brief in Support of Apotex’s Petition in Amgen v. Apotex

Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of...more

Biosimilars Council Files Amicus Brief in support of Apotex’s Petition for Certiorari in Amgen v. Apotex

As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council...more

Amgen v. Hospira (epoetin alfa): District Court Lets in New Infringement Theories, Not New Defendants

As we previously reported, Amgen has sought to amend its complaint regarding Hospira’s planned epoetin alfa biosimilar to add three new defendants and two theories of infringement. On October 3, 2016, Judge Andrews...more

Litigation Update in Abbvie v. Amgen: AbbVie’s Answer Filed in Response to Amgen’s Counterclaims

Last Friday, AbbVie filed its Answer and Defenses to Amgen’s counterclaims of invalidity and noninfringement for each of the patents-in-suit. Of note, AbbVie stated that it lacked “sufficient knowledge and information to...more

FDA Accepts Coherus’s aBLA for Neulasta® Biosimilar

In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Last week, Coherus announced that FDA has accepted its aBLA. ...more

Amgen v. Apotex: Amgen Appeals Non-Infringement Judgment in Filgrastim/Pegfilgrastim Dispute

Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in...more

Amgen Appeals Loss of Neulasta® and Neupogen® Litigation

On October 3, 2016, Amgen filed a Notice of Appeal in the U.S. District Court for the Southern District of Florida and thereby laid the groundwork for its next move in the ongoing Amgen v. Apotex dispute. (D.I. 272.)...more

Litigation Update: Answer Filed in AbbVie v. Amgen

Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501). Amgen asserts...more

Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic...more

Humira Biosimilar Approved As Litigation Gets Going

The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more

Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue

Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more

FDA Approves Amjevita -- Amgen's HUMIRA® Biosimilar

On September 23, 2016, the FDA approved Amgen's application to market Amjevita (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab) fully human anti-TNF-a antibody. This marks the fourth biosimilar approved by the...more

BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab...more

Apotex to Supreme Court: Review BPCIA 180-Day Notice Requirement

On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves...more

Amgen Argues “Entire Balance of BPCIA” in Jeopardy unless Federal Circuit Overturns Discovery Ruling

In its brief filed September 12, 2016, Amgen asks the Federal Circuit to reverse Judge Andrews’ (Civil Action No. 15-cv-00839, D. Del.) decision denying its motion to compel discovery of information related to cell culture...more

Amgen v. Apotex, Petition for Certiorari

We have been closely following the Amgen v. Apotex case. On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision. In its petition, Apotex presents two questions for...more

The Dance Continues: Apotex Petitions the Supreme Court for Review

On September 9, 2016, Apotex Inc. petitioned the United States Supreme Court for a writ of certiorari seeking review of the Federal Circuit’s July 2016 ruling in Amgen v. Apotex (Apotex) holding that the 180-day commercial...more

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

Amgen v. Hospira: Amgen Files Appeal Brief at Federal Circuit

As we reported in August, the Federal Circuit denied Hospira’s motion to dismiss Amgen’s interlocutory appeal from the district court (D.Del., J. Andrews) regarding a discovery dispute. The court ordered the parties to brief...more

Samsung Bioepis Biosimilars Update

According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...more

Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more

Amgen Loses BPCIA Suit Against Apotex’s Neulasta® and Neupogen® Biosimilars

Amgen’s claims against Apotex’s Neulasta® (pegfilgrastim) and Neupogen® (filgrastim) biosimilars have failed at the district court level. On September 6, 2016, the District Court for the Southern District of Florida found no...more

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

Breaking News: Apotex Does not Infringe Amgen’s Filgrastim and Pegfilgrastim Patent; Apotex is Permanently Enjoined From Launch...

The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). The...more

Litigation Update: Amgen v. Hospira (epoetin alfa)

A couple of updates on Amgen v. Hospira (epoetin alfa): Amgen has requested that the district court (D. Del., J. Andrews) grant it leave to file a second amended complaint “to add three additional defendants” who, Amgen...more

232 Results
View per page
Page: of 10
JD Supra Readers' Choice 2016 Awards

"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:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.