ARTICLES BY ANNA ROSE

• The Past, Present, & Future of Biosimilar Manufacturing

  A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.

• Is Biopharma Suffering From Thalassophobia? FDA Regulator Says Yes

  As an FDA regulator explored in a recent presentation, biopharmaceutical manufacturing innovation has not kept pace with R&D. He shared several thoughts on why this may be the case, offering a call-to-action for the industry to reevaluate its notions of value to encourage greater manufacturing innovation.

• The Intriguing FDA News You May Have Missed

  In recent weeks, The Biosimilars Forum announced via press release that it had submitted commentary to the FDA’s notice entitled, “Examination of Secondary Claim Disclosure and Biosimilar Disclosures in Prescription Drug Promotional Materials.” Here’s what you should know about the FDA’s latest notice.

• Rituxan Biosimilars In The Real World: Market And Clinical Considerations

  Following publication of the Future Oncology paper, I connected with one of its co-authors, hematologist Dr. Chadi Nabhan, to hear his thoughts on how biosimilar rituximab will integrate into the standard of care (especially in the face of novel lymphoma therapies), and how he envisions a real-world approach for rituximab and other oncology biosimilars taking shape.

• Biosimilar News You May Have Missed During COVID-19

  There have been a few exciting pieces of news and industry movements that are worth noting as we approach fall. I anticipate these topics will continue to come up and/or shape biosimilar conversations in the years ahead. 

• Sandoz: Critical Initiatives For The New Canadian “Biosimilars Generation”

  Following the launch of The Biosimilars Generation, I sat down with Sandoz's Karine Matteau. In addition to sharing the goals of the educational initiative, she also discussed how biosimilar companies and governments can encourage greater biosimilar buy-in among all stakeholders.

• Celltrion: Shaking Up Biosimilars One Bioinnovative At A Time

  In this Q&A, HoUng Kim, Head of the Medical and Marketing Division at Celltrion Healthcare, shares the biggest market-related considerations and regulatory challenges facing a biosimilar company exploring both biosimilars and bioinnovative products.

• Sandoz President: Managing The Biologics, Biosimilars Supply Chain Through COVID-19

  In this Q&A, Carol Lynch, President, U.S. and Head North America for Sandoz, discusses the supply challenges she’s observed in the biologics space throughout the current pandemic and the efforts biosimilar makers should be taking to meet patients’ needs and prepare for future supply disruptions.

• Oncology Biosimilars: Prepare For A Non-Buy & Bill World

  Given the financial toxicity and evolutions in oncology reimbursement models, one physician argues that the biosimilar discussion needs to evolve in a few key ways.

• Cardinal Health Biosimilars VP Reveals Goals For Improving Rheumatology Uptake

  Following a new Cardinal Health survey on biosimilars in rheumatology, Cardinal Health's VP of biosimilars shared how she plans to use the survey findings as a jumping off point for Cardinal Health (with its manufacturing partners) to improve biosimilar education and engage the rheumatology community.