Amgen

News & Analysis as of

Genentech Files DJ Action Against Amgen Regarding Avastin Biosimilar

Big Molecule Watch frequently posts on BPCIA litigation. As our readers know, the interpretation of various provisions of the BPCIA is currently before the Supreme Court in Sandoz v. Amgen, which we most recently covered...more

Biosimilar Litigants Square Off Before the Supreme Court

Last week, Sandoz filed its opening Supreme Court brief, asking the Court to determine (1) whether notice of commercial marketing under Subsection (l)(8)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) is...more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

Amgen Reports on Neulasta, Neupogen Biosimilar Competition and Acceptance of Avastin Biosimilar aBLA

On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year. According to Amgen Executive Vice...more

Supreme Court Grants Certiorari in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Supreme Court to Consider BPCIA Requirements for Biosimilars

The Supreme Court of the United States has granted certiorari in a case involving the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the context of a biosimilars dispute. Sandoz, Inc. v. Amgen Inc. and...more

Amgen Receives Positive CHMP Opinion for its Biosimilar Adalimumab

Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending...more

Sandoz’s Enbrel Biosimilar on Hold Until Patent Case Resolved

As we reported last August, the FDA has already approved Erelzi®, Sandoz’s biosimilar version of Amgen’s psoriasis drug Enbrel.® However, the head of generics at Novartis (Sandoz’s parent) told Reuters this week that their...more

Biosimilars: What to Expect in 2017

2016 was a record year for the development of biologics in the United States. Below, we summarize a few key biosimilar developments to keep an eye on in 2017. SCOTUS Review of Amgen v. Sandoz - In 2016, Amgen,...more

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

Supreme Court to Review BPCIA -- Amgen v. Sandoz Petitions for Writs of Certiorari Granted

On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court on February 16, 2016...more

Breaking News: Supreme Court Grants Petition and Cross-Petition for Certiorari in Amgen v. Sandoz

The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz. The Order is excerpted below and can be found here...more

Update: Praluent® Permanent Injunction Stay Extended to 45 Days

We reported last week that a permanent injunction against the sale of Praluent® (alirocumab) was issued in Amgen v. Sanofi/Regeneron. The day after the court’s order, defendants filed a motion to stay the injunction while...more

Breaking News: Court Grants Permanent Injunction Against Sale of Praluent® in AMGEN V. SANOFI/REGENERON

For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes...more

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

Confidentiality in BPCIA Cases

The Biologics Price Competition and Innovation Act (“BPCIA”) contemplates the exchange of highly sensitive information from the pre-suit “patent dance” (see, e.g., 42 U.S.C. 262 (l)(2)(A)) throughout litigation, bringing...more

Year In Review: The Top-Five U.S. Market Developments of 2016

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more

When Time is Money

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Good Things Come in Small Packages: M.D. Fla. Rejects Plaintiff’s Discovery Gotcha Gamesmanship

This is the time of year for Best and Worst lists. Our own lists of the best and worst drug and device law decisions of 2016 will be coming out soon. Meanwhile, we have no doubt that the worst moments in our own day-to-day...more

Biosimilars: Solicitor General Recommends Granting Certiorari in Amgen v. Sandoz

Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195)....more

Solicitor General Claims Error in Federal Circuit’s Sandoz Holding

On Monday, December 12, 2016, the Supreme Court denied certiorari in Apotex v. Amgen, No. 16-332. Apotex had petitioned the Court to clarify provisions of the Biologics Price Competition and Innovation Act (BPCIA) set forth...more

Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen

The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more

Amgen and Allergan Submit European Application for Avastin® Biosimilar

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Claim Terms Are Construed In Erythropoietin Case

Andrews, J. Claim construction opinion issues regarding two terms from one patent. A Markman hearing took place on September 21, 2016. The disputed technology relates to pharmaceutical compositions containing isoforms...more

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