• How Can Biosimilars Make Headway In The U.S. Market?
    How Can Biosimilars Make Headway In The U.S. Market?

    ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.

  • USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    USP Highlights Biosimilar Analytical Development Challenges, Possibilities

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  • FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
    FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

    In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

  • Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance
    Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance

    Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

  • Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
    Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

  • Physicians Speak Out About Biosimilar Value
    Physicians Speak Out About Biosimilar Value

    I particularly enjoyed a conversation amongst a panel of physicians at a recent conference, several of whom elaborated upon the value increased use of biosimilars can bring to the table — both for patients and physicians. And though savings and access are main goals, physicians also see another critical benefit of greater biosimilar use.

  • Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?
    Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  • How Should We Really Feel About FDA’s Biosimilar Interchangeability Guidance?
    How Should We Really Feel About FDA’s Biosimilar Interchangeability Guidance?

    Reading through the two versions of the guidance, I had a few thoughts about some of these changes, which led me to reflect more broadly on their impact on the biosimilar regulatory and development sphere.

  • 4 Takeaways From The FDA’s Insulin Hearing
    4 Takeaways From The FDA’s Insulin Hearing

    Overall, four talking points arose during the presentations that I felt were worthy of briefly singling out. Many of these points touch on the broader discussions happening in the biosimilar sphere, including tailored development, interchangeability, immunogenicity, device innovation, and overall patient and provider education.

  • The China Biosimilars Market: Rise Of A Potential Powerhouse
    The China Biosimilars Market: Rise Of A Potential Powerhouse

    Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the US. How does the rise of the China biosimilars market fit this established picture?

  • 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.

  • 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 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.

  • 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.    

  • Guidelines To Bring Your Biologic To Market: Are You Prepared?
    Guidelines To Bring Your Biologic To Market: Are You Prepared?

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  • 3 Crucial Discussions From The Biosimilar Medicines Conference
    3 Crucial Discussions From The Biosimilar Medicines Conference

    After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.

  • Translating Patient And Physician Needs Into Biosimilar Education
    Translating Patient And Physician Needs Into Biosimilar Education

    As we see more real-world evidence (RWE) released in the gastroenterology community, I wanted to learn how one patient advocacy organization is approaching biosimilar education, what challenges the organization is facing, and how the industry and FDA can better reach patients and physicians.

  • Top 4 Takeaways From The BioTech Pharma Summit
    Top 4 Takeaways From The BioTech Pharma Summit

    Last week, I had the pleasure of chairing the first day of the BioTech Pharma Summit: Biologics and Biosimilars conference in the gorgeous Porto, Portugal. (Don’t ask me how much I spent on port wine in the days before the conference.) The conference was — shockingly — the first European biosimilar conference I have attended in my tenure as a biosimilars editor. (Even though Europe is leaps and bounds — and then more bounds — ahead of the U.S. with biosimilars.)

  • Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses
    Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses

    Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.

  • How Well Are Your HCP ELISAs Covered?
    How Well Are Your HCP ELISAs Covered?

    Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.

  • Why, Why, Why… ELISA? A Look At The Benchmark HCP Assay
    Why, Why, Why… ELISA? A Look At The Benchmark HCP Assay

    Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.

  • Biosimilars And The Site Of Care: Current Considerations
    Biosimilars And The Site Of Care: Current Considerations

    At the CBI Biosimilars Summit in January, I had the pleasure of moderating a panel comprising three experts, including Jesse Peterson, clinical development manager at Fairview Specialty Pharmacy. The topic of conversation was stakeholder education, which Peterson is well-equipped to speak about, given his position at regional specialty pharmacy. In his role, Peterson works with experts across the pharmacy operations team and manages relationships with the health system’s payer partners and manufacturers. He is responsible for sharing updates on the future of the specialty pipeline internally and with payers, as well as identifying areas where potential savings could be realized.

  • How Can Manufacturers, Oncologists Prepare For The Oncology Biosimilar Boom?
    How Can Manufacturers, Oncologists Prepare For The Oncology Biosimilar Boom?

    A few months ago, I read a fabulous Q&A in Managed Care Magazine featuring oncologist Gary Lyman and co-director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center. In this day and age, we regularly come across surveys or discussions emphasizing how much more work we have to do in the education realm to ensure physicians’ comfort with biosimilars. But after reading Lyman’s interview on one cold, dreary January day, I felt buoyed. That’s not to say there isn’t more work to be done, of course. But it was reassuring to see a prominent member of the oncology community express such comfort and confidence in biosimilars.

  • Biosimilar Success: It’s Not As Risky To Attain As We Think
    Biosimilar Success: It’s Not As Risky To Attain As We Think

    In the first of what will be two articles, I walk you through a high-level model forecast Engert shared to demonstrate that the value-capture possible after developing a biosimilar is much higher than what we may assume. In order to receive these rewards, however, there are five steps Engert outlines that a company must take to properly manage the risks that arise.

  • 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.

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