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Life Sciences Biosimilars Drug Pricing

Venable LLP

Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila

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On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila....more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Goodwin

Year in Review: Top Regulatory Developments of 2024

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As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

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On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Hogan Lovells

JPM2023 Trendspotting: takeaways from Biotech Showcase

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At the recent J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry led in-person discussions with industry experts on topics that will guide...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

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2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

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As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Smart & Biggar

Update on biosimilars in Canada - October 2021

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Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more

Proskauer - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

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Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

Goodwin

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

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On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Patent Thickets and Regulatory Challenges Cited as Major Factors Limiting Price Reductions in the Biologic Drug Space

The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: November 2019

Congressional Developments on Life Science and Consumer Product Issues - Legislation - Citizen Petitions: House Subcommittee Approves Bill to Prevent Overuse - To address the abuse of citizen petitions that delay...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - October 2019

In This Issue - 1. Drug Manufacturing: Sen. Grassley Pressures Company Over Data Manipulation - 2. Medical Product Innovation: Update to 21st Century Cures Act in the Works - 3. Drug Pricing: Senate Finance...more

Hogan Lovells

Administration presents plans to lower drug prices

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On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

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Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Smart & Biggar

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Blake, Cassels & Graydon LLP

Trends in Life Sciences: From Data Protection to Drug Pricing

As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more

WilmerHale

M&A: The Last Refuge for Biotechs Seeking Funding

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These are tough times in the biotech and pharmaceutical industries: Funding is drying up, investors are fleeing the space, the IPO door is pretty firmly shut, valuations are dropping, activists are lurking and the headlines...more

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