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Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
On July 2, 2024, Fresenius Kabi (“Fresenius”) announced the immediate availability of TYENNE (tocilizumab-aazg), in a subcutaneous formulation, in the United States....more
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more
On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell...more
On March 5, 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab-aazg) as a biosimilar of Chugai, Genentech and Hoffman-La Roche’s Actemra® (tocilizumab). ...more
On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union....more
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more
Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen’s NEULASTA, in the United States. As we previously reported, STIMUFEND was Fresenius Kabi’s first biosimilar...more
Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA. IDACIO is approved for use in the treatment of chronic autoimmune...more
On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021. Yuflyma™ was approved across all...more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)....more
Case Name: Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC, Civ. No. 15-1102-GMS, 2018 U.S. Dist. LEXIS 93911 (D. Del. June 5, 2018) (Sleet, J.)....more
Case Name: Fresenius Kabi USA, LLC v. Fera Pharms., LLC, No. 15-cv-3654 (KM)(MAH), 2016 U.S. Dist. LEXIS 128126 (D.N.J. Sept. 20, 2016) (McNulty, J.) - Drug Product and Patent(s)-in-Suit: Levothyroxine Sodium for...more
Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more