Steven Kozlowski

Director of the Office of Product Quality Assessment III in the Office of Pharmaceutical Quality, CDER, FDA. The views and information presented here are mine.

[Steven Kozlowski @BiotechKoz]

Having a shared systematic way to describe protein characteristics and analytical methodologies offers great promise in advancing development and lifecycle management of therapeutic proteins. This is discussed in a new publication https://t.co/Ql5SX1rSu5

[Steven Kozlowski @BiotechKoz]

We evaluated whether dispensing pharmacy chains for two anticoagulants were associated with differences in clinical outcomes for Medicare beneficiaries. There were differences for one anticoagulant in a subset of exploratory analyses. https://t.co/Kqg9NziM0m

[Steven Kozlowski @BiotechKoz]

Biosimilar Uptake: This cross-sectional study generally observed greater biosimilar market share in Medicare Advantage than in Traditional Medicare with a median increase in market share of 5.7%. Biosimilars can increase access and reduce healthcare costs.
https://t.co/78Kg7e6BCh

[Steven Kozlowski @BiotechKoz]

https://t.co/zeeNaEbHI4

[Steven Kozlowski @BiotechKoz]

Sharing a CDER Conversation on implementation of the Biosimilar User Fee Amendments:
CDER Conversation: Biosimilar User Fee Amendments Latest Implementation: BsUFA III | FDA

[Steven Kozlowski @BiotechKoz]

Biosimilar uptake varies by product and is generally lower than generic drug uptake. In the Medicare FFS population, there were no clear trends in non-interchangeable biosimilar uptake by order of entry, care setting, or initial discounts. https://t.co/LX3wqj7Wl0

[Steven Kozlowski @BiotechKoz]

FDA approves an insulin as the first interchangeable biological product. This is an important achievement for people who rely on insulin for treatment of diabetes and a regulatory milestone. Thanks to all the OPQ and CDER staff inv…https://t.co/2Y4NB1gEhy https://t.co/yWZwHrPF4D

[PLOS Pathogens @PLOSPathogens]

Early antibody responses associated with survival in #COVID19 patients

New from Zhao-Hua Zhou, @BiotechKoz and colleagues @US_FDA
https://t.co/jHUarA292h

[Steven Kozlowski @BiotechKoz]

Thank you to OPQ staff for all their quality work in supporting the emergency use authorization of sotrovimab. Additional monoclonal antibody therapeutics for COVID19 are important in the context of SARS-CoV2 variants. https://t.co/MUphGccoTY

[Steven Kozlowski @BiotechKoz]

Nice work by #OPQ Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment on another #COVID19 EUA. https://t.co/l8BKf7SoMb

[Steven Kozlowski @BiotechKoz]

Nice work by #OPQ Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment on this #COVID19 EUA.

[U.S. FDA @US_FDA]

Today, we issued an emergency use authorization (EUA) for two monoclonal antibodies to be administered together for the treatment of mild to moderate #COVID19 in high-risk adults and pediatric patients age 12 and older. https://t.co/BJWrhdoIiA

[Steven Kozlowski @BiotechKoz]

Nice work by #OPQ Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment in Contributing to this EUA

[Dr. Stephen M. Hahn @SteveFDA]

Today, the FDA issued an EUA for an investigational monoclonal antibody therapy for treating #COVID19, illustrating our commitment to expediting the development & availability of treatments & providing sick patients timely access to new therapies. https://t.co/JEmL3PrTZp

[Steven Kozlowski @BiotechKoz]

A comprehensive scientific survey of excipients for biological product was published based on the #FDA #OPQ Office of Biotechnology Products formulation database. Excellent work by the authors in providing this important resource. https://t.co/QTtZNZ6ITd

[Steven Kozlowski @BiotechKoz]

Nice work by #FDA #OPQ staff in the Office of Biotech Products & Office of Pharmaceutical Manufacturing Assessment who contributed to assessing and approving this breakthrough therapy for treatment of Ebola virus infection.

[FDA Drug Information @FDA_Drug_Info]

#FDAapproves first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients: https://t.co/blUc6qu9vm

[FDA Drug Information @FDA_Drug_Info]

#FDAapproves first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients: https://t.co/blUc6qu9vm

[FDA Drug Information @FDA_Drug_Info]

FDA announces new option for CDER NextGen Portal users to submit manufacturing capacity data to FDA to analyze and support manufacturing efforts for CDER products to treat or prevent #COVID19.

Resources available at: https://t.co/KERzwoViVZ and https://t.co/bsCok1Lw8X

[Steven Kozlowski @BiotechKoz]

We are committed to making decisions guided by the best evidence. Our approach has been and must remain the gold standard that all can rely upon.” #FDA #OPQ https://t.co/ccDYDBXfhT

[Steven Kozlowski @BiotechKoz]

Nice work by #FDA #OPQ staff in the Office of Biotech Products, Office of New Drug Products & Office of Pharmaceutical Manufacturing Assessment who all contributed to assessing and approving this interesting new product, Sogroya (somapacitan). https://t.co/0jWty3sBiD

[Steven Kozlowski @BiotechKoz]

New commentary in @NatImmunol by #FDA #OPQ staff from a symposium on the role of cytokines (signals of our immune system) in #COVID19. The event featured Anthony Fauci, Janet Woodcock of Operation Warp Speed & more - will be another in December! https://t.co/PrFAqoxarb

[Steven Kozlowski @BiotechKoz]

It was great to participate for #FDA #OPQ Office of Biotech Products in the @NIH Operation Warp Speed Neutralizing Antibodies Scientific Summit last week on antibodies against #COVID19. See my panel discuss assay standardization at 3:00:00. https://t.co/RF8kW57V3u