Biosimilars

News & Analysis as of

Celltrion Files Petition for IPR on Genentech’s Rituximab Patent

Yesterday, Celltrion filed a petition for inter partes review of Genentech’s U.S. Patent No. 7,976,838, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on...more

Court Invalidates Janssen Remicade® Patent for Double Patenting; Celltrion Seeks Speedy Appeal

Janssen’s suit against Celltrion in the District of Massachusetts (C.A. No. 1:15-cv-10698) relating to a biosimilar of Janssen’s Remicade® (infliximab) is one of the few currently pending BPCIA litigations. Over the last...more

What's in a Name? A Quick Guide to Biologic Drug Names

We have previously reported on the complicated naming issues surrounding biosimilar products and how biological qualifiers, such as three or four-letter codes, should be added to distinguish between them. However, the...more

Update in Janssen v. Celltrion: Parties Stipulate that Celltrion Will Not Sell Remicade Biosimilar Before October 3, 2016

In a stipulation filed yesterday in Janssen v. Celltrion, Celltrion has agreed not to sell its Remicade biosimilar in the U.S. for use by doctors or patients before October 3, 2016, and the parties have agreed to dismiss all...more

Celltrion Begins Shipping Remsima to the U.S.

As we reported last week, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion. The Korea Times reports that Celltrion shipped its...more

BREAKING NEWS: Summary Judgment, Claim Construction, Consolidation, Bifurcation, and Trial Schedule Order Issued in Janssen v....

Following three days of hearings in Janssen v. Celltrion, the District Court for the District of Massachusetts (J. Wolf) today issued a memorandum order summarizing the Court’s rulings on several pending motions in the case....more

BPCIA Litigation Roundup (Summer 2016)

Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product....more

IPR Petition Filed on Genentech Patent Directed to Method of Producing Polypeptides

On August 16, bioeq filed a petition for inter partes review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to...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

Survey Suggests Pharmacists Prefer Non-Proprietary Proper Names for Biosimilars

The August, 2016, edition of the Journal of Managed Care & Specialty Pharmacy published the results of a survey designed to measure pharmacists’ view on biosimilar naming conventions. (See our previous posts here and here...more

Biosimilars Development Updates

According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70%...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...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

JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more

UPDATE Janssen v. HyClone: HyClone files a motion for injunctive relief to dismiss and to stay

As we previously reported, on June 17, Janssen filed two complaints alleging infringement of claims in U.S. Patent No. 7,598,083, one against Celltrion and Hospira, and one against HyClone Laboratories, Celltrion’s supplier...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

Coherus Submits 351(K) BLA Application to FDA for Pegfilgrastim Biosimilar

Coherus Biosciences, Inc. announced submission to the FDA of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Pegfilgrastim is used to prevent or treat neutropenia, a...more

AbbVie Sues Amgen On 10 Of 100 Humira Patents

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins

To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more

EMA Accepts Mylan and Biocon’s Application for Authorization to Market a Pegfilgrastim Biosimilar

Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe,...more

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61...more

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