• 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.

     

  • The Transparent CDMO: Maintaining Autonomy In Your Biomanufacturing Partnership
    The Transparent CDMO: Maintaining Autonomy In Your Biomanufacturing Partnership

    Complete transparency and open communication are critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

  • Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs
    Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

    Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

  • Working With Patient Groups To Strengthen Biosimilar Understanding In The U.S.
    Working With Patient Groups To Strengthen Biosimilar Understanding In The U.S.

    When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will ultimately require more than communicating successful clinical trial results. Here, we unpack several strategies patient advocacy groups have indicated to be essential for successfully reaching patients.

  • Why The Biosimilar Industry Should Celebrate The Latest FDA News
    Why The Biosimilar Industry Should Celebrate The Latest FDA News

    A number of articles already provide a synopsis of the FDA's reversal on the Statistical Approaches draft guidance. But I felt it was necessary to add one more article to this conversation, not only because this action is unprecedented thus far in the biosimilar industry, but it also suggests an important turning point in the FDA’s biosimilar oversight.

  • The Benefits Of Flow Cytometry In Immuno-Oncology Research
    The Benefits Of Flow Cytometry In Immuno-Oncology Research

    Flow cytometry introduces a powerful and versatile technology into studies, enabling in-depth analysis of cell signaling and behavior.

  • “Locally Brilliant": 3 Biosimilar Market Access Experiences
    “Locally Brilliant": 3 Biosimilar Market Access Experiences

    Mundipharma expert Richard Trollope shares his learnings from launching three different biosimilar molecules (Remsima, Truxima, and Herzuma) in the EU and discusses the questions that remain about the newly launched Herzuma, recently introduced in the U.K. and Germany.

  • Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China
    Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China

    As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.

  • 4 Conversations Integral To Building Biosimilar Partnerships
    4 Conversations Integral To Building Biosimilar Partnerships

    Thanks to Mundipharma's Richard Trollope, I not only got the inside scoop on what makes a biosimilar partnership specifically a biosimilar partnership, but also Mundipharma’s journey in launching Remsima, Truxima, and, most recently, Herzuma.

  • Critique Of Literature Review Highlights Areas For Future Study And Education
    Critique Of Literature Review Highlights Areas For Future Study And Education

    A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.

  • Considering A Future In Biosimilars: The Small Biotech Perspective
    Considering A Future In Biosimilars: The Small Biotech Perspective

    A small biotech company faces specific challenges when navigating both the biosimilar and the innovative space. I wanted to get a better sense of how smaller companies originally defined as biosimilar pure-plays, like Pfenex, are ensuring longevity in the biosimilars space.

  • Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility
    Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility

    I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.

  • How Social Media Can Support #Biosimilars
    How Social Media Can Support #Biosimilars

    In the countless moments I’ve spent scrolling through social media platforms, a few ways they’re being used by pharma companies, organizations, and patients have caught my eye. Though they aren’t all posts about biosimilars, I think they’re worth calling attention to as potential strategies for biosimilar companies.

  • How These Key Learnings Shaped Pfizer’s Biosimilar Business
    How These Key Learnings Shaped Pfizer’s Biosimilar Business

    It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.  

  • Economics And The Clinic: What Biosimilar Manufacturers Must Consider
    Economics And The Clinic: What Biosimilar Manufacturers Must Consider

    In the second of this two-part article, McKesson Specialty Health's Omar Hafez and Pete Perron discuss how to approach the complex financial landscape in the clinic and help incentivize clinics to use biosimilars.

  • The How and Why of Normalizing Your Western Blots
    The How and Why of Normalizing Your Western Blots

    How normalization can help you be confident that your data is not being skewed by experimental errors.

  • Nunc Roller Bottles Excel With ST, Vero, And MDBK Cells Application Note
    Nunc Roller Bottles Excel With ST, Vero, And MDBK Cells Application Note

    A third-party study was conducted to compare the performance of Thermo Scientific™ Nunc™ Roller Bottles (1.2 and 2.5X) and 850 cm2 roller bottles from another supplier, for the culturing of ST, Vero, and MDBK cells.

  • Rapid, Serum-Free, High-Yield Antibody Production In Nunc PETG Roller Bottles
    Rapid, Serum-Free, High-Yield Antibody Production In Nunc PETG Roller Bottles

    A rapid, flexible, and high-yield approach for both hybridoma expansion and for antibody production using a serum-free medium in Nunc PETG Roller Bottles.

  • 3 Biosimilar Barriers In Community Clinics
    3 Biosimilar Barriers In Community Clinics

    In the first of this two-part article, McKesson experts share insights on two biosimilar barriers they’ve noticed in community clinics and highlight their takeaways from infliximab’s and filgrastim’s experiences tackling these barriers.

  • 90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?
    90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?

    This review sought to answer two questions which have been plaguing the biosimilar industry since day one: will biosimilar switching have any impact on safety, and will biosimilars be the harbingers of increased immunogenicity? And it has provided us with far more than just answers to these questions.

  • Does The U.S. Biosimilar Space Have A Case Of “Progressophobia?”
    Does The U.S. Biosimilar Space Have A Case Of “Progressophobia?”

    A prediction that a failure of the U.S. biosimilars market could lead to the end of the global biosimilars market begs the question of how we evaluate progress, as well as how such a prediction could be avoided.

  • Could This Stakeholder Lead The Biosimilar Charge?
    Could This Stakeholder Lead The Biosimilar Charge?

    Many have predicted payers will be the stakeholders to carry biosimilars across the finish line. But as the past few years will attest, this has not turned out to be the case, and this realization leaves the biosimilar industry asking an important, somewhat nerve-wracking question:

  • Views From The U.K.: What Biosimilar Evolutions Are Worth Watching?
    Views From The U.K.: What Biosimilar Evolutions Are Worth Watching?

    The first of this three-part article touches on the current biosimilar-related developments ongoing in the U.K., as well as what the new chair of the British Biosimilars Association (BBA) is keeping her eyes on, both in the U.K. and globally.

  • Accurate Comparability Assessment Of A Biosimilar Interferon In Process Development
    Accurate Comparability Assessment Of A Biosimilar Interferon In Process Development

    This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and Amersham™ WB system in the development of a biosimilar.

  • Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”
    Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

    There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

  • AmerisourceBergen: Responsible Pricing, Patient Programs Biggest Biosimilar Challenges
    AmerisourceBergen: Responsible Pricing, Patient Programs Biggest Biosimilar Challenges

    In the first part of this two-part article, we touched on the two strategies for distributing biosimilars. In this article, Lozano highlights some of the common topics that pose the greatest challenges for manufacturers, in particular pricing their products and establishing patient and provider services. 

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