Anna Rose Welch

Anna Rose Welch

Anna R. Welch is the executive editor for Biosimilar Development.com. She writes features on the latest news, issues, and trends in the biosimilar industry.

ARTICLES BY ANNA ROSE

  • Top 5 Biosimilar Developments Of 2016
    Top 5 Biosimilar Developments Of 2016

    In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

  • The Case For Moving The EMA To Ireland
    The Case For Moving The EMA To Ireland

    Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.

  • How To Approach U.S. Physicians About Biosimilars
    How To Approach U.S. Physicians About Biosimilars

    As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.

  • How To Make The Most Of Your FDA Biosimilar Meetings
    How To Make The Most Of Your FDA Biosimilar Meetings

    The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.

  • How These Biosimilar Unknowns Could Impact Manufacturers
    How These Biosimilar Unknowns Could Impact Manufacturers

    During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

  • 3 Big Biosimilar Questions At DIA 2016
    3 Big Biosimilar Questions At DIA 2016

    So far this year, I've attended three biosimilar conferences, the most recent being DIA Biosimilars 2016.  While all three events touched on the broad (and often political) biosimilar challenges, including reimbursement, naming, interchangeability, and patient access, DIA offered a special glimpse into the more nitty-gritty challenges of biosimilar development. 

  • FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews
    FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews

    A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?

  • 3 Lessons From The GPhA Biosimilars Council Conference
    3 Lessons From The GPhA Biosimilars Council Conference

    This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets, and IP challenges. But I felt three overarching topics were particularly worthy of being singled out.

  • Tips For Efficient Comparator Sourcing In Biosimilar Clinical Trials
    Tips For Efficient Comparator Sourcing In Biosimilar Clinical Trials

    There is a lot of pressure for companies to accelerate the clinical development of a biosimilar to make it to market before it becomes overcrowded. One challenge facing companies is comparator sourcing for their Phase 1 and Phase 3 trials. As one expert outlines, there are two different strategies, each presenting drugmakers with different benefits and challenges.

  • Best Practices For Maintaining A Blind In Biosimilar Clinical Trials
    Best Practices For Maintaining A Blind In Biosimilar Clinical Trials

    A more aggressive clinical timeline for biosimilars can get a candidate to market more quickly. But it also becomes more difficult to ensure that clinical trial personnel running biosimilar trials clearly understand their roles and responsibilities, especially when it comes to maintaining a blind. There are several things for sponsors to consider in order to ensure the right people in the trial remain blinded.

More From Anna Rose Welch