Amgen

News & Analysis as of

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

FDA Approves Third Biosimilar Product

As we predicted in a previous post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its...more

FDA Approves Sandoz’s Biosimilar of Enbrel®

Yesterday, the FDA approved its third biosimilar product, Sandoz’s biosimilar version of Amgen’s Enbrel® (etanercept). The drug, named Erelzi (etanercept-szzs), was approved for the same indications listed on Enbrel®’s...more

Enbrel Biosimilar Approved in US But Enjoined For Now

On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions. The...more

Biosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products –...more

The Ripple Effect of the Federal Circuit’s Decision in Amgen v. Apotex on Biosimilar Litigation

In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009...more

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more

Amgen v. Hospira: Amgen’s Appeal to the Fed. Cir. Will Proceed on the Merits

As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to...more

Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order

The Federal Circuit has denied Hospira’s motion to dismiss Amgen’s appeal of a discovery order in an underlying BPCIA district court litigation (Civil Action No. 15-cv-00839, D. Del.) and has instructed the parties to address...more

Apotex Files Petition for IPR On Amgen’s Neulasta Patent

On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the District Court for the Southern District of Florida, in a case in...more

UPDATE Amgen v. Apotex: Amgen argues they have met their burden to prove infringement

As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written...more

Apotex Takes Aim at Amgen Patent in IPR Petition After Being Sued Under the BPCIA

Many biosimilar applicants have resorted to inter partes review (IPR) proceedings to challenge innovator patents as an alternative forum to district court litigation under the BPCIA. For those biosimilar applicants that...more

BPCIA Litigation Updates: Amgen v. Apotex, Immunex v. Sandoz, Janssen v. Celltrion

A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: ..The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the...more

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