ARTICLES BY ANNA ROSE WELCH

  • Comparative Biosimilar Clinical Trials: More Questions Than Answers?
    Comparative Biosimilar Clinical Trials: More Questions Than Answers?

    As one expert said, though there are many reasons to praise clinical trials for their contributions to drug development, they may not always be the best method to answer some of the most important biosimilar questions we have today.

  • 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.

  • Two Biosimilar Policies Raise Questions About Reimbursement Consistency
    Two Biosimilar Policies Raise Questions About Reimbursement Consistency

    In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.   

  • Why 2018 Was The Year Of Real-World Evidence For Biosimilars
    Why 2018 Was The Year Of Real-World Evidence For Biosimilars

    Here we unpack some of the most impactful RWE releases or efforts implemented over the past year, as well as which of the biggest biosimilar questions were answered over the past year.

  • Why This Biosimilar Initiative Is One To Watch In 2019
    Why This Biosimilar Initiative Is One To Watch In 2019

    When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.

  • How Can The U.S. Government Take Ownership Of Biosimilars In 2019?
    How Can The U.S. Government Take Ownership Of Biosimilars In 2019?

    Though the FDA has outlined many promising efforts to help the U.S. biosimilar market grow, the biosimilar industry’s public comments reveal an increasing need for the U.S. government healthcare agencies to take even greater charge of biosimilar policy in 2019.

  • Biosimilars Vs. AbbVie So Far: “Humirapocalypse” Or Illusion?
    Biosimilars Vs. AbbVie So Far: “Humirapocalypse” Or Illusion?

    Humira is said to have recently won a national tender in the EU thanks to a startling 80 percent discount to the pre-biosimilar price tag. However, as the dust clears from the initial news, things are less clear-cut than they may have appeared.

  • How The Regulatory Pathway Shapes Biosimilar Business Decisions
    How The Regulatory Pathway Shapes Biosimilar Business Decisions

    A discussion regarding the challenging decisions Pfenex made in the past year regarding its biosimilar pipeline and the company’s efforts getting its teriparatide follow-on ready for the 505(b)(2) pathway.

  • Biosimilar Policies To Watch As We Approach 2019
    Biosimilar Policies To Watch As We Approach 2019

    I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.

  • A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch
    A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch

    In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.

  • Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations
    Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

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

    An exclusive interview with Brian Hosung Min, an SVP and head of drug substance at Samsung Bioepis. He explains the company’s ongoing efforts to realize a lower COGS, speed up production, and manage risk in biosimilar and novel biologics development.

  • 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.

  • Pfizer Executives Elaborate On Biosimilar Goals, Challenges
    Pfizer Executives Elaborate On Biosimilar Goals, Challenges

    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. 

  • 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.

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.