How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?
How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

This article summarizes the key provisions of the new law and discusses its limitations. I then look at the FTC’s practice in evaluating “reverse payment” settlements in Hatch-Waxman litigations and discuss why similar antitrust analyses of biosimilar settlements will likely be more complex.

  • U.S. Biosimilar Progress: Are We Getting Ahead Of Ourselves?
    U.S. Biosimilar Progress: Are We Getting Ahead Of Ourselves?

    Rather than focusing on whether the market has a solid basis to survive, one expert presents some interesting perspectives on the need for a more measured perspective on the market’s financial growth, as well as on the current role of biosimilar competition and differentiation.

  • Mylan’s Pegfilgrastim Journey: Retracing Its Steps Towards Fulphila’s Launch
    Mylan’s Pegfilgrastim Journey: Retracing Its Steps Towards Fulphila’s Launch

    During our conversation, Kokino and I walked through the steps Mylan took to establish this foundation, as well as how the company’s overseas biosimilar experiences influenced its global — including the U.S. — biosimilar launch strategy.  

  • What Does The U.S.-Mexico-Canada Agreement Means For Biosimilars?
    What Does The U.S.-Mexico-Canada Agreement Means For Biosimilars?

    The proposed text of the U.S.–Mexico–Canada Agreement (USMCA) is intended to replace the North American Free Trade Agreement (NAFTA), which has been in place since the mid-1990s. There have been some very strong reactions. Is the USMCA “an important step in bringing Mexico and Canada closer to high U.S. standards” or a crushing blow to patients that will “stifle biosimilar competition"? As with most things, the details will matter, and of course the House and Senate must still approve the agreement. It’s important to consider 1) Whether the 10-year exclusivity impacts the filing of biosimilar applications, 2) What this change means in terms of the prioritization of some medicines from a public policy standpoint, and 3) The impact the agreement has on efforts to make biosimilars more accessible in the U.S.

  • The Top 5 Trends To Watch In Bioprocessing
    The Top 5 Trends To Watch In Bioprocessing

    Biopharmaceutical processes — and the technologies that enable them — have experienced remarkable progress in the past 30 years, since the first biopharmaceuticals were approved for human use. This article will highlight some of today’s top trends in bioprocessing, as this exciting field continues to flourish.

  • Preparing Employers For Biosimilars: What Must They Know Now?
    Preparing Employers For Biosimilars: What Must They Know Now?

    I reached out to several employer groups around the country to learn how each is approaching biosimilars with its members. I also wanted to find out what employers might need from biosimilar companies moving forward. Matt Harman of Employers Health shares his perspective on employers' excitement level over biosimilars and what knowledge they need most.

  • A Biosimilar Manufacturer’s Sword & Shield Against Doctrine Of Equivalents Claims
    A Biosimilar Manufacturer’s Sword & Shield Against Doctrine Of Equivalents Claims

    While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.

  • Biosimilar Policies To Watch As We Approach 2019
    Biosimilar Policies To Watch As We Approach 2019

    I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.

  • The Current State Of U.S. Biosimilar Policies — An Overview
    The Current State Of U.S. Biosimilar Policies — An Overview

    With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry. 

  • A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch
    A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch

    In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.

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Madrid)
Blockchain Technology for the Life Sciences: A Comprehensive Primer November 27 - 27, 2018
1pm-2:30pm EST, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Compliant Patient Support Programs Summit November 28 - 29, 2018
Philadelphia, PA)
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Philadelphia, PA)
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Philadelphia, PA)

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Annual Cardiologists Meeting 2018 November 26 - 27, 2018
Madrid
Blockchain Technology for the Life Sciences: A Comprehensive Primer November 27 - 27, 2018
1pm-2:30pm EST, Online Training
Compliant Patient Support Programs Summit November 28 - 29, 2018
Philadelphia, PA
Clinical Trial Legal and Contracting Forum December 4 - 5, 2018
Philadelphia, PA
Supporting the Patient Experience for Quality Care December 4 - 5, 2018
Philadelphia, PA
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Madrid
Blockchain Technology for the Life Sciences: A Comprehensive Primer November 27 - 27, 2018
1pm-2:30pm EST, Online Training
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Philadelphia, PA
Clinical Trial Legal and Contracting Forum December 4 - 5, 2018
Philadelphia, PA
Supporting the Patient Experience for Quality Care December 4 - 5, 2018
Philadelphia, PA
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