James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses the implications of recent FDA guidance on medical product communications.
Transcript
Recently FDA has changed its guidances on how companies can make communications about their drugs and devices. There [are] actually 2 separate categories: one is economic information, like, for example, is a drug cost effective or how does it say, reduce the length of hospitalization, what kind of money does that save. The other one goes into what kind of communications, what things that companies say that are consistent with the labeling of a product.
Both of these guidances essentially have slightly liberalized what companies can say by giving companies more guidance on what is permissible and what is impermissible. The healthcare economic one, in particular, companies really wanted to see because there have been 2 laws in the last 15 years where Congress asked FDA to do more in that area and give more guidance.
So that one is great now because now we know particularly prior to approval for example, that you can go and talk with payers and show more data about what has this product done in clinical trials.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On 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 Joseph Alvarnas Highlights the Current State of the Oncology Biosimilar Market
November 9th 2022Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.
Expert Opinion: What Factors Will Have the Greatest Impact on US Adoption of Humira Biosimilars?
April 12th 2022Jeffrey Casberg, vice president of pharmacy at IPD Analytics, weighs in on the factors he thinks will most affect market share among adalimumab biosimilars when they enter the US market in 2023.