Anna Rose Welch

Anna Rose Welch



Since the launch of Biosimilar Development in 2015, Chief Editor Anna Rose Welch has conducted interviews and written thought-leadership columns on the biosimilar development, regulatory, policy, and commercialization advances in the global biosimilar industry. She has built an editorial board and interviewed experts from a wide variety of biosimilar stakeholder organizations.

Anna Rose has also been an active participant in the biosimilar conferences circuit. She has been appointed chair or served as a speaker and panel moderator at conferences based in the U.S. and Europe, including the World Biosimilar Congress USA, The Biotech Pharma Summit, the CBI Biosimilars Summit, DIA Biosimilars Conference, and the Biosimilar Medicines Group Conference. In 2018, she was invited to Brazil to address members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilars manufacturers about how to establish a national biologics and biosimilars policy. She has also represented the publication on a media tour of Bangkok, Thailand in 2017, during which she reported on the country’s efforts to bolster its life sciences industry. In addition to writing for Biosimilar Development, she penned the introductory chapter to the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (Springer, 2018).

In 2018, her first book of poetry was published by Alice James Books.

ARTICLES BY ANNA ROSE WELCH

  • Sterile Injectable Outsourcing Trends — What Biosimilar Developers Need To Know
    Sterile Injectable Outsourcing Trends — What Biosimilar Developers Need To Know

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

  • FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics
    FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

  • A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  • Cutting Through The Noise: The Bright Side Of Biosimilar Progress
    Cutting Through The Noise: The Bright Side Of Biosimilar Progress

    Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

  • The Debate On Standards In Biologics Development Heats Up
    The Debate On Standards In Biologics Development Heats Up

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

  • 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.

  • 3 Countries To Watch In The MENA Region
    3 Countries To Watch In The MENA Region

    Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.

  • MENA: Biosimilar Market Challenges And Regulatory Considerations
    MENA: Biosimilar Market Challenges And Regulatory Considerations

    Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.

  • 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.

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