Articles by Anna Rose Welch

91. How Should We Really Feel About FDA's Biosimilar Interchangeability Guidance? 5/20/2019

    Reading through the two versions of the guidance, I had a few thoughts about some of these changes, which led me to reflect more broadly on their impact on the biosimilar regulatory and development sphere.

92. 4 Takeaways From The FDA's Insulin Hearing 5/16/2019

    Overall, four talking points arose during the presentations that I felt were worthy of briefly singling out. Many of these points touch on the broader discussions happening in the biosimilar sphere, including tailored development, interchangeability, immunogenicity, device innovation, and overall patient and provider education.

93. Physicians And Biosimilar Uptake: How Do We Move Forward? 5/13/2019

    Here, I’ll discuss some of the current physician knowledge gaps in the different therapeutic areas. Similarly, I’ll delve into the discussions surrounding what educational strategies and guidelines may be needed on the hospital or national level to improve physicians’ and patients’ relationships with biosimilars.

94. 5 Intriguing U.S. Biosimilar Policy Questions 5/9/2019

    Biosimilar Development recently hosted a webinar on U.S. biosimilar policies with Frier Levitt Government Affairs expert, Ron Lanton. Here are several questions that came up during the webinar about the impact proposed or current policies may have in the future.

95. 3 Countries To Watch In The MENA Region 5/6/2019

    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.

96. MENA: Biosimilar Market Challenges And Regulatory Considerations 4/30/2019

    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.

97. 3 Tips To Advance Biosimilar Education For IBD Patients 4/29/2019

    Whether it be pointing out specific unmet needs in IBD or suggesting meaningful educational materials for patients, one patient advocate delivered great examples of how manufacturers can support patient advocates and provide them with the information they need most today.

98. How Advocacy Groups, Biosimilar Makers Can Improve Biologics Education For Physicians 4/24/2019

    In this first of two articles, an advocate from the Crohn's and Colitis Foundation shares details about the Foundation’s ongoing initiatives in terms of educating physicians, as well as what can be done to better understand and improve physicians’ biologics and biosimilar prescribing practices.    

99. Biosimilars Vs. Interchangeable Biologics: Which Is A Distraction? 4/15/2019

    I found myself puzzled, to say the least, by a recent editorial intriguingly entitled “Biosimilars Are A Distraction.” What I ended up reading were several questionable economic and clinical claims I feel are worth dissecting. 

100. 3 Crucial Discussions From The Biosimilar Medicines Conference 4/9/2019

     After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.