EDITOR'S DESK

  • Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame
    Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame

    Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.

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Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the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

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GUEST CONTRIBUTORS

  • Are “Do-Overs” Practical In Biopharmaceutical Manufacturing?
    Are “Do-Overs” Practical In Biopharmaceutical Manufacturing?

    What should a manufacturer do when an API (drug substance) or intermediate from a biopharmaceutical manufacturing process does not meet specification, or when a process has operated outside the validated operating range?  What if, for instance, a chromatography step does not reduce the host-cell protein content to the required amount due to overload of protein or a variation in buffer pH?

  • Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?
    Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?

    These are formative days for biosimilar developers in the U.S. courts. Last month, the biosimilar market witnessed its first legal settlement, between Mylan and Genentech for trastuzumab, and further settlements are sure to follow. On April 26, the Supreme Court began hearing the case between Amgen and Sandoz regarding the infamous “patent dance.” The Court’s ruling (expected in July) will have significant ramifications on how quickly new biosimilars reach the market.

  • Brexit & The Biopharma Industry: What Happens Next?
    Brexit & The Biopharma Industry: What Happens Next?

    Last year, after the fateful June 2016 Brexit referendum that ended in a shocking win for the “Leave” camp, I wrote an article discussing the options going forward and the uncertainty that faced the biopharmaceutical industry. Now, almost a year later and after the official triggering of Article 50 — through a letter delivered by Eurostar, no less — have we actually learned anything new?

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BIOPROCESSING WHITE PAPERS

  • 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.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Considerations To Ensure Successful Scale-up Of Single-use Processes
    Considerations To Ensure Successful Scale-up Of Single-use Processes

    Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.

  • What’s Next For Single-Use Technology In Bioprocessing
    What’s Next For Single-Use Technology In Bioprocessing

    The advantages of single-use are well-known — faster, smaller, greener, cheaper, and safer — and increasing numbers of biomanufacturers have sought to reap these benefits, especially as patent expiration and increasingly globalized manufacturing continues to change the dynamics of biomanufacturing.

  • 3 Steps To Prepare For FDA’s Final Quality Metrics Guidance
    3 Steps To Prepare For FDA’s Final Quality Metrics Guidance

    Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

  • CDMOs — At The Core Of Next-Generation Pharma Models
    CDMOs — At The Core Of Next-Generation Pharma Models

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.

     

  • Ensuring Barcode Accuracy From Packaging To The Patient
    Ensuring Barcode Accuracy From Packaging To The Patient

    Barcodes have changed very little over the last 60 years. Yet for pharmaceutical companies the barcode has taken on a vital role throughout the product’s lifecycle from original packaging to in hospital unit dose identification.

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