Steven Kozlowski

44 posts

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Steven Kozlowski

Steven Kozlowski

@BiotechKoz

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.

Katılım Mayıs 2020
45 Takip Edilen74 Takipçiler
Steven Kozlowski
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 rdcu.be/dPDfI
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Steven Kozlowski
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. onlinelibrary.wiley.com/doi/10.1002/pd…
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Steven Kozlowski
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. jamanetwork.com/journals/jama-…
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Steven Kozlowski
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
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Steven Kozlowski
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. rdcu.be/cOM3Q
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Steven Kozlowski
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…lnkd.in/ewHNr6p lnkd.in/e6h7YgD
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Steven Kozlowski
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. lnkd.in/eUjFsw6
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Steven Kozlowski
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. lnkd.in/ekTEsaM
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Steven Kozlowski retweetledi
FDA Drug Information
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: go.usa.gov/xG6Mq and go.usa.gov/xG6Mc
FDA Drug Information tweet media
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Steven Kozlowski
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 lnkd.in/erPvbj4
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Steven Kozlowski
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). lnkd.in/etJUiy6
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Steven Kozlowski
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! lnkd.in/e9nBmUv
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Steven Kozlowski
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. lnkd.in/eyJGg88
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Keşfet

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