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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Articles

In 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 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

Patient Surveys Provide Insight Into Real-World Adalimumab Biosimilar Use in IBD

Although 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.

Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.


Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?

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1rem

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how specialty pharmacists manage inventory, storage, and handling of biosimilars. 

Dr Fran Gregory Discusses the Unique Requirements for Handling Biosimilars

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses the importance of collaboration between all stakeholders to boost confidence in providing patients with a biosimilar drug. 



Dr Fran Gregory: Providing Patients With High-Quality Biosimilars Is a Collaborative Effort 

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses what the future biosimilars marketplace may look like compared with generics and reference products at Asembia 2023.

Dr Fran Gregory Discusses the Future Landscape of the Biosimilars Marketplace

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how the use of biosimilars in other countries strengthens the acceptance and approval of these products in the United States. 

Dr Fran Gregory: What Can We Learn From Biosimilar Use in Other Countries? 

Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discusses the use of biosimilars and how pharmacy benefit managers (PBMs) as well as payers have challenged the biosimilar market.

Kathy Oubre Discusses PBM, Payer Challenges for Biosimilar Adoption

Pearl Steinzor

Articles