1. Building Thailand’s Biosimilar Industry From The Ground Up

    As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.

  2. Supreme Court Biosimilar Decision — What Developers Need To Know

    When the U.S. Supreme Court granted certiorari in the Sandoz v. Amgen litigation earlier this year, many were hoping for a decision that would clarify some key issues pertaining to the requirements of the BPCIA. But the decision left a number of questions unanswered.

  3. The Thai FDA’s Approach To Biologics And Biosimilars

    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.   

  4. The U.S. Biosimilar Market: Where Is It Today? Where Is It Going?

    The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.

  5. Integrating The Payer Perspective Into Drug Development

    In the last decade, the healthcare industry has witnessed significant changes, some of which present important challenges to how pharmaceutical companies develop drugs. One such challenge is the shift in influence from the physician to the payer in the adoption of new interventions. This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.

  6. 5 Tips For Orphan Drug Development In A Price-Sensitive Payer Environment

    The first installment in this two-part series examined rising costs associated with orphan drugs and two related case studies. This second part provides actionable suggestions for developers.

  7. Supreme Court’s Amgen v. Sandoz Decision: More Questions Than Answers?

    On June 12, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted.

  8. A Deep Dive Into Brazil’s Biosimilar PDPs

    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). 

  9. Chinese & Indian Expectations For GMP Biologics Exports — A Comparative Assessment

    In our studies we asked respondents to indicate their facility’s primary objectives for biologics production today and in 10 years. We found that in China, 70 percent of biopharma facilities today are primarily focused on production for domestic consumption.

  10. 5 Biosimilar Questions: The Payer Perspective (Part 2)

    In this article (the second of two parts), experts from a regional and national payer elaborate on some of their expectations for the market and how they — in partnership with companies — can encourage biosimilar acceptance.