• How Can The FDA Take Ownership Of Biosimilars In 2019?
    How Can The FDA Take Ownership Of Biosimilars In 2019?

    In lieu of the slow development of the U.S. biosimilar market, the FDA has stepped up to determine how it can improve biosimilar education, regulation, and market access. As many of the industry comments to the Biosimilar Action Plan revealed, this will require the FDA to continue broadening its purview and refining the regulatory pathway by implementing several specific actions.

  • The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?
    The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?

    In this article, I’ll discuss the importance of one commonly overlooked expert and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.  

  • West Coast Employers Eye Biosimilars
    West Coast Employers Eye Biosimilars

    One employer group expert provides a good look at the current relationships between employers and those assisting them with their healthcare decisions, as well as how the Pacific Business Group on Health, has set out to create a biosimilar educational and market push initiative.

  • An Inside Look: The Oncologist’s Perspective On Biosimilars
    An Inside Look: The Oncologist’s Perspective On Biosimilars

    Biosimilar Development regularly discusses educational strategies and biosimilar market access strategies implemented around the world. However, one perspective that deserves more attention (on this site and elsewhere) is that of oncologists. After all, these are the experts on the front lines, experiencing manufacturers’ education strategies and influencing biosimilar uptake.

  • Reaching Employers: How Biosimilar Makers Can Close The Gap
    Reaching Employers: How Biosimilar Makers Can Close The Gap

    In addition to learning about the biosimilar-related activities National Alliance of Healthcare Purchasers Coalition has implemented recently, I picked one expert's brain about which educational strategies would best reach employers during this age when the entire U.S. healthcare system is under the microscope.

  • Biosimilars Vs. AbbVie So Far: “Humirapocalypse” Or Illusion?
    Biosimilars Vs. AbbVie So Far: “Humirapocalypse” Or Illusion?

    Humira is said to have recently won a national tender in the EU thanks to a startling 80 percent discount to the pre-biosimilar price tag. However, as the dust clears from the initial news, things are less clear-cut than they may have appeared.

  • 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.  

  • 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 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.

  • Market Research Report: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition)
    Market Research Report: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition)

    A biosimilars boom is expected and both biopharma and contract manufacturers want to be positioned to capture a piece of the market. ISR’s Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition) goes into depth on one of the most important aspects of biosimilars: manufacturing.

  • Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations
    Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

  • The Humira Biosimilar Tsunami Cometh: What Can We Expect?
    The Humira Biosimilar Tsunami Cometh: What Can We Expect?

    In the first segment of this two-part Q&A article, da Silva and Heller share their perspectives on the EU market potential for Humira biosimilars, which markets they expect will be most dynamic from a competition standpoint, and what Humira biosimilar players can learn from previous tumor necrosis factor (TNF) biosimilar launches.

  • Biosimilar Education: The Elements Of An Effective Strategy
    Biosimilar Education: The Elements Of An Effective Strategy

    In this first of what I expect will be several articles, I will lay out one of the current educational gaps I’ve noticed, as well as introduce real educational examples or efforts I’ve encountered (or would like to see more of) that show promising and widely adaptable pathways forward.

  • Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access
    Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access

    Low- and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.

  • Charting A Biosimilar Course In Low- And Middle-Income Nations
    Charting A Biosimilar Course In Low- And Middle-Income Nations

    Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.

  • The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing
    The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing

    How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?

  • How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?
    How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?

    Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?

  • Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?
    Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.

  • 4 Revelations From The FDA’s Biosimilar Part 15 Hearing
    4 Revelations From The FDA’s Biosimilar Part 15 Hearing

    In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time. 

  • Biosimilar Access: Is The Industry Overlooking Critical Markets?
    Biosimilar Access: Is The Industry Overlooking Critical Markets?

    Though there’s much to write about the successes and pitfalls in the European, U.S., and Canadian biosimilar markets, it turns out there’s quite a bit that biosimilar makers need to learn about the countries off the beaten market-access path. And in many of these nations, the capacity for a biologics market already exists.

  • What Brazil Can Learn From Denmark’s Biosimilar Policies
    What Brazil Can Learn From Denmark’s Biosimilar Policies

    In this article I continue to outline some of the Brazil Ministry of Health's biggest questions about post-market surveillance, big data, and procurement, as these are particularly telling of how the nation’s biosimilar policy could take shape in the future.

  • How The Regulatory Pathway Shapes Biosimilar Business Decisions
    How The Regulatory Pathway Shapes Biosimilar Business Decisions

    I took the opportunity to pick editorial board member Hubert Chen's brain about the ins and outs of the 505(b)(2) pathway, which led to an even larger discussion about the critical impact a regulatory pathway can have on a company's business decisions and strategies.

  • What Can Biosimilar Developers Learn From The 1990s Biopharma Industry?
    What Can Biosimilar Developers Learn From The 1990s Biopharma Industry?

    This article highlights some of the early biologics industry decisions and thought processes and the subsequent actions and opportunities biosimilars create for the pharma industry.

  • Biosimilars In Brazil: Healthcare Salvation Or Waterloo?
    Biosimilars In Brazil: Healthcare Salvation Or Waterloo?

    I was recently given a first-hand look at some of the unique market-related challenges standing in the way of Brazil taking full advantage of biosimilars. In the first of this two-part article, I will provide a closer look at some of these challenges and what these may mean for the Brazilian biosimilar industry moving forward.  

  • A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief
    A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

    This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.

  • One Way Biosimilar Manufacturers Could Improve Payer Relationships
    One Way Biosimilar Manufacturers Could Improve Payer Relationships

    Outside the world of rebate traps, product bundling, and seemingly water-tight innovator contracting efforts, there is certainly still room for biosimilar manufacturers to improve their own payer strategies. Ned Pojskic, an expert from Green Shield Canada, shares one simple solution.

  • Biosimilars Conquer Factual Hurdle, Now Face “Emotional Hurdle”
    Biosimilars Conquer Factual Hurdle, Now Face “Emotional Hurdle”

    Conversations about biosimilars amongst stakeholders are beginning to shift in the way that we’d like them to. The industry no longer needs to (stringently) justify the science so much as provide information on how the product can be used. One expert shares some recent revelations she plans to turn into actionable strategies in her role at Mylan and with Medicines for EU.

  • Innovators' Next-Gen Strategy: Is Obsolescence The Best Biosimilar Defense?
    Innovators' Next-Gen Strategy: Is Obsolescence The Best Biosimilar Defense?

    As biosimilars are targeting drugs with more than $5 billion in annual revenue, the originator manufacturers desperately need to find ways to either defend or replace that revenue. Strategies have included portfolio contracting, rebating, patent pursuits, supply chain differentiation, licensing deals, and building customer loyalty.

  • The Search For Biosimilar Value: The Devil Is In The Details
    The Search For Biosimilar Value: The Devil Is In The Details

    In many situations, value is associated with the price tag, and, specifically, the savings associated with a certain product. But there are still questions of how biosimilar value can be presented to stakeholders, especially since it can feel as though there is a missing part in the equation.

     

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