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aBLA

Venable LLP

Celltrion Submits aBLA for CT-P39, Proposed Interchangeable Biosimilar of Xolair® (omalizumab)

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On March 10, 2024, Celltrion announced in a press release that it submitted an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P39 (omalizumab), a proposed interchangeable biosimilar of Genentech’s /...more

Venable LLP

Accord’s aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA

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According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab), a proposed biosimilar to Janssen...more

Venable LLP

EYLEA® (aflibercept) and Soliris® (eculizumab) IPR Updates

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On December 8, 2023, the PTAB instituted three of Samsung Bioepis’s pending IPRs against Alexion’s Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999. The challenged patents include composition of matter,...more

Venable LLP

Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®

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On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more

Goodwin

Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars

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On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and...more

Goodwin

Accord BioPharma Announces the Acceptance of BLA for HLX02 (a proposed trastuzumab biosimilar) by FDA

Goodwin on

On April 5, 2023, Accord BioPharma announced that the FDA has accepted the Biologics License Application (BLA) for HLX02 referencing HERCEPTIN (trastuzumab) for adjuvant treatment of HER2-overexpressing breast cancer and...more

Goodwin

Innovent Announces Results of Phase III Trial of Sintilimab and Bevacizumab Combination Therapy In Patients With Advanced Lung...

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Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. ...more

Mintz - Intellectual Property Viewpoints

N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA

In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss...more

King & Spalding

“Purple Book” Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect?

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The Biological Product Patent Transparency Act (“BPPT”) – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genentech, Inc. v. Immunex Rhode Island Corp. (Fed. Cir. 2020)

In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Holds That Amendments to Biosimilar’s BLA Do Not Trigger Anew BPCIA’s Notice of Commercial Marketing Provision

Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar.  ...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Supplementation of aBLA Does Not Trigger New Notice of Commercial Marketing Obligations

The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics Price Competition and...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Biosimilar Guidance for Label Carve-Outs and Supplements

On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more

Patterson Belknap Webb & Tyler LLP

Hospira Seeks En Banc Review of the Federal Circuit’s “Safe Harbor” Ruling in Amgen v. Hospira

In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more

Goodwin

DEAL WATCH: Biosimilars, Biosimilars and More Biosimilars

Goodwin on

It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a...more

Patterson Belknap Webb & Tyler LLP

Amgen Files New Patent Infringement Suit Over Neupogen Biosimilar

On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar...more

Akin Gump Strauss Hauer & Feld LLP

Prosecution History Estoppel Bars Amgen’s Infringement Claim Under the Doctrine of Equivalents

The Federal Circuit affirmed a district court decision barring Amgen from asserting an infringement claim under the doctrine of equivalents against Coherus Biosciences because Amgen disclaimed all combinations not identified...more

Patterson Belknap Webb & Tyler LLP

Prosecution History Estoppel Bars Amgen’s Doctrine-of-Equivalents Infringement Claim Against Neulasta (Pegfilgrastim) Biosimilar...

Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market...more

K&L Gates LLP

Amgen v. Sandoz - New Developments in Biosimilars Litigation

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INTRODUCTION & BACKGROUND - On May 8, 2019 in Amgen, Inc. v. Sandoz International GmbH, the Federal Circuit Court affirmed the district court’s judgment, concluding that the district court correctly construed the claims and...more

Fish & Richardson

Amgen v. Sandoz: Final Judgment of Non-Infringement: Clearance for Biologics Still Being Finalized at the Time of Judgment?

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Decisions in the Amgen v. Sandoz case involving Sandoz’s biosimilar versions of Amgen’s Neupogen® and Neulasta® drugs have provided significant guidance to biosimilar litigants over the years.  ...more

Dechert LLP

Federal Circuit Panel Describes the Doctrine of Equivalents as Applying “Only in Exceptional Cases”

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In a patent owner’s declaratory judgment action under the Biologics Price Competition and Innovation Act (“BPCIA”) a Federal Circuit panel in Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. May 8, 2019) narrowly...more

Goodwin

Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

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Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Ask FTC to Investigate Biosimilar Litigation Settlement Agreement

The high cost of biologic drugs was one of the (if not the) most compelling motivations for Congress to adopt a biosimilar pathway as part of the Affordable Care Act in 2010 (aka "Obamacare"). Passage of the Biologic Price...more

Mintz - Health Care Viewpoints

Biosimilars in the Limelight – A Lot Has Happened Since January 2018

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory...more

Patterson Belknap Webb & Tyler LLP

First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation

As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is...more

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