Biosimilar Regulatory solution center

31. 3 Pressing Questions From The FDA/FTC Biologics Competition Workshop 3/13/2020

    After taking at least 20 pages of notes from the FDA/FTC biologics competition workshop, I’ve whittled my takeaways down to three overarching questions that provide necessary considerations and industry action steps moving forward. 

32. How Biosimilars, Biobetters Fit Into Value-Based Healthcare 3/3/2020

    As the buck falls on physicians and healthcare systems to better control the cost of care, I wanted to hear from Dr. Chadi Nabhan about the value-based care models he’s been watching and how biosimilars (and biobetters) could fit into the overarching goals of these arrangements.

33. How Can Hospitals Lead The Biosimilar Charge? 2/25/2020

    One oncology expert shares his thoughts on the operational challenges biosimilars may pose hospitals and what biosimilar manufacturers need to consider as they continue to invest in and launch oncology biosimilars.

34. Sandoz Executives: Have Biosimilars Lived Up To Their Promise? 1/13/2020

    I had the fortune of talking with two U.S. Sandoz executives, Sheila Frame, VP, marketing, market access, and patient services, and William Yoon, head, external engagement and medical advocacy. In the first of this two-part article, I picked their brains about the progress they’ve observed and how challenges for the industry have evolved over the past 10 years.

35. 6 Important Elements Of The New STRONGER Patents Act 1/9/2020

    Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.

36. Biosimilar Industry Advancements To Watch In 2020 1/8/2020

    Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

37. Fresenius Kabi: The Quest For More Efficient Biosimilar R&D 1/6/2020

    Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

38. The Top 7 Biosimilar Developments of 2019 12/30/2019

    I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

39. What Does 2020 Hold For Biosimilars? Industry Experts Weigh In 12/18/2019

    As we face 2020, several big questions remain from the past year and about what the future may (or may not) bring for the industry. Here, these 19 experts pose their biggest questions for the new year, as well as how they anticipate or hope these questions could be answered.

40. Biosimilar Industry Experts Highlight 2019 Triumphs, Tribulations 12/11/2019

    As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.