In addition to challenges related to reliable power, connectivity, transportation, and clean water, Puerto Rico
On Friday, FDA Commissioner Scott Gottlieb, MD,
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
How Streamlining Development Can Save the US Biosimilar Industry
August 20th 2023On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.
Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward
September 20th 2023In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing
September 18th 2023Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.
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