Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents
Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents

In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.

  • Physicians And Biosimilar Uptake: How Do We Move Forward?
    Physicians And Biosimilar Uptake: How Do We Move Forward?

    Here, I’ll discuss some of the current physician knowledge gaps in the different therapeutic areas. Similarly, I’ll delve into the discussions surrounding what educational strategies and guidelines may be needed on the hospital or national level to improve physicians’ and patients’ relationships with biosimilars.

  • 5 Intriguing U.S. Biosimilar Policy Questions
    5 Intriguing U.S. Biosimilar Policy Questions

    Biosimilar Development recently hosted a webinar on U.S. biosimilar policies with Frier Levitt Government Affairs expert, Ron Lanton. Here are several questions that came up during the webinar about the impact proposed or current policies may have in the future.

  • How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA
    How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  • 3 Countries To Watch In The MENA Region
    3 Countries To Watch In The MENA Region

    Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.

  • MENA: Biosimilar Market Challenges And Regulatory Considerations
    MENA: Biosimilar Market Challenges And Regulatory Considerations

    Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.

  • HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?
    HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?

    On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”

  • 3 Tips To Advance Biosimilar Education For IBD Patients
    3 Tips To Advance Biosimilar Education For IBD Patients

    Whether it be pointing out specific unmet needs in IBD or suggesting meaningful educational materials for patients, one patient advocate delivered great examples of how manufacturers can support patient advocates and provide them with the information they need most today.

  • Incorporating Natural Hazards & Distributed Infrastructure Into Risk Management For Biopharma Operations
    Incorporating Natural Hazards & Distributed Infrastructure Into Risk Management For Biopharma Operations

    Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.

  • How Advocacy Groups, Biosimilar Makers Can Improve Biologics Education For Physicians
    How Advocacy Groups, Biosimilar Makers Can Improve Biologics Education For Physicians

    In this first of two articles, an advocate from the Crohn's and Colitis Foundation shares details about the Foundation’s ongoing initiatives in terms of educating physicians, as well as what can be done to better understand and improve physicians’ biologics and biosimilar prescribing practices.    

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BIOSIMILAR INSIGHTS

  • Virus Reduction Of An Affinity Capture Step - Viral Clearance For Protein A

    Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.

  • Viral Clearance: The Basics On How To Conduct Effective Studies

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  • Your Strategy To Manufacture, No Longer A One-Size-Fits-All

    The traditional method of big batch manufacturing must change as biopharmaceutical companies move away from the one-size-fits-all blockbuster pharmaceutical model toward increasingly more innovative, targeted biologics that deliver better patient outcomes.

  • The Value Of Digital In Biopharma

    By working together across the biopharma industry, digital technology can be leveraged and data science can reengineer key elements of the drug manufacturing process to ease commercial scale-up.

  • Translating Biopharma Knowledge To Cell And Gene Therapies

    Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

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