• Biosimilar Makers To Congress: Time To Act On REMS Legislation
    Biosimilar Makers To Congress: Time To Act On REMS Legislation

    REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.

The 4 Most Notable Biosimilar Interchangeability Hurdles

Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.

IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment

I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.

Should Your Biosimilar Really Be A Biobetter?

A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

Celltrion: Data Transparency Imperative For Biosimilar Success

Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

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  • Automating Compliance Operations Using Motor, Sensor, & Decider Bots
    Automating Compliance Operations Using Motor, Sensor, & Decider Bots

    Life sciences businesses need to move quickly and innovate. Compliance is often seen as a brake that slows businesses down, and in some cases it may become a barrier to innovation.

  • Biosimilars & Generics: Are The Market Comparisons Valid?
    Biosimilars & Generics: Are The Market Comparisons Valid?

    The U.S. biosimilar market is in its infancy, with only four products approved by the FDA and only two currently on the market. Passed over 30 years ago, the Hatch-Waxman Act, which allowed generic competition for branded drugs, has proven successful in decreasing drug prices while still encouraging innovation. Will the availability of biosimilars have a similar effect on the biologics market? There has been much debate in the industry concerning the future of biosimilars and how analogous they are to the generic market.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)
    5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)

    This article explains the critical components of a compliant disinfectant efficacy testing package in the U.S.,  along with tips for assembling the package.

  • How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.

  • What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

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  • The Future of BioManufacturing

    The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

  • Checklist For Multivariate Analysis Best Practice

    You are unlikely to create the final model in your first attempt. Use the power of multivariate analysis to select interesting samples based on the instrumental measurements before you put them through the lab.

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  • Single-Use Tech And Sustainability: Quantifying The Environmental Impact
    Single-Use Tech And Sustainability: Quantifying The Environmental Impact

    In the shift to single-use technology, there is both an opportunity and an obligation to understand the sustainability impacts of this development.

  • Making Novel Therapies A Reality Part 1
    Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  • Understanding Analytical Method Validation

    During my years in analytical development science at biotechnology companies including Celera and Genentech, it became routine to develop analytical assays to test products such as proteins, monoclonal antibodies, recombinant protective antigen, DNA, RNA, etc. These tests were predominantly developed on high performance liquid chromatography (HPLC), mass spectroscopy (MS), DNA sequencers, and other state-of-the-art techniques.

  • Shift From Central Lab To POC
    Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  • The Standardization Of Single-Use Components For Bioprocessing
    The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology.

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