Amgen

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Courts Answer Key Questions Over the Reach of the BPCIA

Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

Biosimilars Development Updates

We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more

Amgen and Allergan Report Progress in Herceptin® Biosimilar Clinical Trial

In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more

FDA Issues Complete Response Letter for Sandoz’s Neulasta® Biosimilar

As we’ve previously reported, Sandoz is seeking approval of an aBLA for its proposed biosimilar to Neulasta® (pegfilgrastim), which is currently the subject of a BPCIA litigation (Civil Action No. 3:16-cv-02581 (N.D. Cal.)) ...more

ANDA Update - Volume 2, Number 2

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Washington Healthcare Update

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

The Commercial Marketing Provisions of the Biologics Act are Mandatory

In Amgen Inc. v. Apotex Inc., [2016-1308] (July 5, 2016), the Federal Circuit affirmed a preliminary injunction against Apotex from entering the market until 180 days after giving Amgen Notice after receiving its FDA license....more

Biosimilar “Patent Dance” Does Not Permit Sidestepping of 180-Day Notice

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more

Fall-Out from the Federal Circuit’s Decision in Amgen v. Apotex

The repercussions of Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016) (“Apotex”), continue as BPCIA litigants submit letters to their respective judges addressing the Federal Circuit’s latest ruling on the Act’s notice...more

FDA Advisory Panels Considering Approvals of Two Biosimilars This Week

An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s...more

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)

Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more

Notice of Commercialization Is Only Effective After FDA-Approval Regardless of Whether Parties Dance

In Amgen v. Apotex, the Federal Circuit affirmed the district court’s ruling that Notice of Commercial Marketing under the BPCIA is only effective after FDA approval of a biosimilar, even when the parties engage in the...more

Financial Services Quarterly Report - Second Quarter 2016: Does the Supreme Court’s Dudenhoeffer Decision under ERISA do “More...

Earlier this year, the U.S. Supreme Court decided the case of Amgen v. Harris, in which the Court revisited and clarified its 2014 holding in Dudenhoeffer v. Fifth Third Bancorp.2 Both cases concern the application of a...more

FDA: Amgen’s Biosimilar “Highly Similar” to Abbvie’s Humira

A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to...more

Federal Circuit Holds Again That BPCIA's 180-day Notice Is Mandatory

On July 5, 2016, the Federal Circuit affirmed a district court's preliminary injunction against proposed biosimilar manufacturer Apotex, holding that Apotex was enjoined from entering the market until Apotex: (1) provides...more

New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’

The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing. The ruling weighed in on a key...more

FDA's Draft Guidance to Help Manufacturers in Labeling Biosimilars

The passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 paved the way for the introduction of biosimilars in the United States. Biosimilars are large-molecule drugs that are highly similar, but not...more

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

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