Articles by Anna Rose Welch

  1. 90 Studies Prove Biosimilars’ Safety And Efficacy: What Now? 3/27/2018

    This review sought to answer two questions which have been plaguing the biosimilar industry since day one: will biosimilar switching have any impact on safety, and will biosimilars be the harbingers of increased immunogenicity? And it has provided us with far more than just answers to these questions.

  2. DIA Biosimilars Conference Reveals “More Questions Than Answers” 10/31/2017

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

  3. A Glimpse Into Thailand’s Ongoing Life Sciences Transformation 5/18/2017

    During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

  4. What Thailand Revealed About U.S. Pharma R&D 5/16/2017

    A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

  5. What To Know About Thailand’s Life Sciences Industry 5/12/2017

    About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.

  6. The 4 Most Notable Biosimilar Interchangeability Hurdles 3/1/2017

    Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the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

  7. IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment 2/27/2017

    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.

  8. Top 5 Biosimilar Developments Of 2016 12/29/2016

    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.

  9. The Case For Moving The EMA To Ireland 12/13/2016

    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.

  10. How To Approach U.S. Physicians About Biosimilars 11/21/2016

    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.