• Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

  • 2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach
    2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach

    Just as the FDA emphasized that companies should take a “step-wise” approach to biosimilar development, I’d argue this same approach needs to be embraced in our commercialization and education efforts moving forward.

  • Chasing The Biopharma Market
    Chasing The Biopharma Market

    From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?

  • Speed Biologics To Clinical Trials Faster
    Speed Biologics To Clinical Trials Faster

    If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.

  • The Evolving Landscape Of Medical Science Liaisons
    The Evolving Landscape Of Medical Science Liaisons

    Though the report does not focus specifically on the role of MSLs in the biosimilar space, there were a few salient points to note for biosimilar companies as they consider the evolving roles and integration of these teams.

  • Why This Biosimilar Initiative Is One To Watch In 2019
    Why This Biosimilar Initiative Is One To Watch In 2019

    When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.

  • Biosimilar “Fake Views” Roundup
    Biosimilar “Fake Views” Roundup

    The end goal of this creative biosimilar-related work of fiction is to reflect upon and make light of the most prominent market hurdles we’ve faced thus far in the biosimilar industry.

  • Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges
    Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges

    As we enter 2019, editorial board experts share their thoughts on what challenges will be top-of-mind for biosimilar companies, trade groups, and payers, as we progress into the new year.

  • Top 5 Biosimilar Developments Of 2018
    Top 5 Biosimilar Developments Of 2018

    As the industry matures, I’m finding it harder and harder to single out one specific news headline as being the most influential. Rather, each of these Top 5 encompasses a series of events that, together, have further defined and carried this industry forward.

  • How This Employer-Driven Initiative Could Revolutionize Biosimilar Use
    How This Employer-Driven Initiative Could Revolutionize Biosimilar Use

    Using what The Coalition’s President and CEO Troy Ross has termed “3D thinking” through the creation of data mapping, employers are gaining access to information they’ve never been privy to before that will enable them to identify savings opportunities and better design their benefits — which could mean increased traction for biosimilars.

  • What Biosimilar Metamorphoses Are In Store For 2019?
    What Biosimilar Metamorphoses Are In Store For 2019?

    In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.

  • 2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?
    2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?

    In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.

  • 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?

More From Biosimilar Development solution center