From The Editor

  1. The Thai FDA’s Approach To Biologics And Biosimilars
    7/19/2017

    This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.   

  2. A Deep Dive Into Brazil’s Biosimilar PDPs
    7/5/2017

    In terms of life sciences, Brazil is best known as a small molecule pharmaceutical market; some of the largest companies in Brazil are small molecule generics companies. But, in recent years, the country has identified the importance of establishing a biotechnology industry. Enter the productive development partnerships (PDPs). 

  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. Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame
    4/18/2017

    Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.

  7. 3 Notable Trends In Amgen’s 2017 Biosimilar Report
    4/13/2017

    The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.

  8. Biosimilar Makers To Congress: Time To Act On REMS Legislation
    3/27/2017

    REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.

  9. 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.

  10. 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.