News & Analysis as of

Mylan Pharmaceuticals Food and Drug Administration (FDA)

Robins Kaplan LLP

Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. - Xarelto® (Rivaroxaban)

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Case Name: Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024) (Hatcher, M.J.) - Drug Product and Patent(s)-in-Suit: Xarelto® (rivaroxaban); U.S. Patents Nos....more

Eversheds Sutherland (US) LLP

Third Circuit holds patent infringement fees do not facilitate ANDA approval

In an opinion released July 27, 2023, the Third Circuit affirmed a 2021 Tax Court decision upholding a pharmaceutical company’s immediate deduction of patent defense litigation costs in suits brought under the Hatch-Waxman...more

Goodwin

Expedited Trial Ordered in Regeneron Aflibercept BPCIA Case Against Mylan

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The court has issued a scheduling order in Regeneron’s aflibercept BPCIA case against Mylan. The court scheduled a 2-week trial in June 2023, less than a year from Regeneron’s filing of its complaint in August 2022....more

Fish & Richardson

Federal Circuit Clarifies Venue in Hatch-Waxman Actions in Celgene v. Mylan

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The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more

Skadden, Arps, Slate, Meagher & Flom LLP

The Tax Court Offers a Mixed Bag in the Mylan Case

In Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (April 27, 2021), the Tax Court held that legal expenses incurred by a manufacturer of generic pharmaceutical drugs for the preparation, assembly and transmittal...more

Robins Kaplan LLP

Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.

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Jublia® (efinaconazole) - Case Name: Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.,978 F.3d 1374 (Fed. Cir. Nov. 5, 2020)(Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by O’Malley, J.) (Appeal from D.N.J.,...more

Goodwin

FDA Defers Decision on Bevacizumab Biosimilar

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The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more...more

Goodwin

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2020

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As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more

Fenwick & West LLP

Valeant v. Mylan: Restrictions on Venue in Hatch-Waxman Litigation

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For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...more

Robins Kaplan LLP

Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc.

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Colcrys®/colchicine - Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., No. 2020-1407, -1417 (Fed. Cir. July 31, 2020) (Circuit Judges Prost, Newman, and Hughes presiding; Opinion by Prost, C.J.; Dissent by...more

Robins Kaplan LLP

Valeant Pharms Int’l, Inc. v. Mylan Pharms Inc.

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BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more

Goodwin

FDA Approves Mylan’s Biosimilar of HUMIRA (Adalimumab)

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On July 6, 2020, the U.S. FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA. HULIO is indicated for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis,...more

Goodwin

FDA Approves NDA for Semglee (insulin glargine injection)

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Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.  Semglee’s amino acid...more

Robins Kaplan LLP

Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc.

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Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc., No. 19-2216-RGA, 2020 U.S. Dist. LEXIS 12753 (D. Del. Jan. 27, 2020) (Andrews, J.)....more

Goodwin

Biosimilars Development Updates: Mylan’s Pipeline, Coherus’s Adalimumab aBLA, Amgen’s Eculizumab Biosimilar

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Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s...more

Kramer Levin Naftalis & Frankel LLP

US Biosimilar Market Expands As BPCIA Turns 10

The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more

Goodwin

Biosimilar Developers Comment on Regulatory Delays

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Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. ...more

Goodwin

EYLEA (Aflibercept) Biosimilar Development Updates

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Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more

Goodwin

FDA Accepts Mylan’s Bevacizumab Biosimilar Application

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Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with a user fee goal date of December 27, 2020. ...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

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BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...more

Goodwin

U.S. Biosimilar Launches: Mylan/Biocon’s Trastuzumab, Sandoz’s Pegfilgrastim

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Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab). According to the press release, “OGIVRI™ is approved for all indications of...more

Robins Kaplan LLP

Valeant Pharms. N. Am. LLC v. Zydus Pharms. (USA) Inc.

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BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more

Goodwin

Biosimilar Development Updates: BOTOX, RITUXAN, EYLEA

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Below are some highlights of recent news in biosimilar development: Earlier this week, Mylan and Revance Therapeutics, who are collaborating in developing a biosimilar of BOTOX (onabotulinumtoxinA), reported on their...more

Patrick Malone & Associates P.C. | DC Injury...

Price-fixing scandal ensnares ‘white-hat’ makers of lower-cost generic drugs

To paraphrase what a one-time colleague once wrote about her bosses: Never trust Big Pharma, never trust Big Pharma, never trust Big Pharma. Here’s some of the latest evidence why: Even the industry’s so-called “white hats,”...more

Goodwin

EMA’s CHMP Recommends Approval of Three Biosimilars

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The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions,...more

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