From The Editor

  1. Top 5 Biosimilar Developments Of 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.

  2. Health Canada’s Unique Approach To Biosimilar Regulation

    Health Canada recently released its revised guidance document on biosimilar submission requirements. Though the revisions were primarily “clarifications,” not major policy changes, some of these amendments provide a glimpse into the more unique aspects of Canada’s relationship with biosimilars.

  3. The Case For Moving The EMA To Ireland

    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.

  4. Congress Takes On Biosimilars

    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.

  5. FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars

    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. 

  6. The Many Gray Areas Of Biosimilar Commercialization

    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.

  7. How To Approach U.S. Physicians About Biosimilars

    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.

  8. How To Make The Most Of Your FDA Biosimilar Meetings

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

  9. How These Biosimilar Unknowns Could Impact Manufacturers

    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.

  10. What You Need To Know To Launch Biosimilars Globally

    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.