Articles by Anna Rose Welch

71. Congress Takes On Biosimilars 12/9/2016

    During an interview at a briefing held by The Atlantic and The Biosimilars Council, Senator Bill Cassidy of Louisiana presented some valuable insights into where he believes more work needs to be done to ensure biosimilars’ market success.

72. FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars 12/5/2016

    In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries. 

73. The Many Gray Areas Of Biosimilar Commercialization 11/29/2016

    Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.

74. 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.

75. How To Make The Most Of Your FDA Biosimilar Meetings 11/14/2016

    The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.

76. How These Biosimilar Unknowns Could Impact Manufacturers 11/10/2016

    During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

77. What You Need To Know To Launch Biosimilars Globally 11/7/2016

    In a biosimilar conference presentation, Suzette Kox of the International and Generic and Biosimilars Medicines Association laid out the unique regulatory frameworks in several countries, highlighting the challenges facing companies planning to launch products globally. 

78. Biosimilar Lessons From The EU 10/26/2016

    Suzette Kox, the senior director of the Biosimilars Medicines Group and chair of the biosimilars committee of the International Generic and Biosimilar Medicines Association, offers the European perspective on several topics that are currently being debated in the U.S.

79. For U.S. Biosimilar Success, Look Beyond Borders 10/14/2016

    In any industry, there are the experts who become known as the foremost voices of the industry. Biosimilar evangelist, Bert Liang, CEO of Pfenex and chair of the Biosimilars Council describes how far the U.S. biosimilar industry has progressed, as well as how far it has yet to go, offering biosimilar makers some important goals to strive for.

80. FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews 9/28/2016

    A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?