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Pharmaceutical Industry › Food and Drug Administration (FDA) › BsUFA

Goodwin

FDA Seeks Input on Biosimilar Product Development Guidance

Goodwin on

​​​​​​​On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of...more

Hogan Lovells

FDA seeks industry input on biosimilar guidance development

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the establishment of a public docket to obtain information and comments to help FDA assess how best to advance the development of new biosimilar biological...more

Goodwin

FDA Accepts Xbrane’s sBLA for LUCENTIS® (Ranibizumab) Biosimilar Candidate

Goodwin on

​​​​​​​ On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS® (ranibizumab) biosimilar...more

Goodwin

Biocon and Alvotech Release Statements on FDA Inspections

Goodwin on

​​​​​​​On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Goodwin

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Goodwin on

Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee...more

Bergeson & Campbell, P.C.

FDA Requests Comments On Reauthorization Of BsUFA

Bergeson & Campbell, P.C. on

On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027....more

Baker Donelson

Recent FDA Plan to Improve Marketplace for Biosimilars

Baker Donelson on

The Biologics Price and Competition and Innovation Act (BPCI Act) established an abbreviated pathway for biologics, called biosimilars, in 2010. The FDA has committed to encourage the development of biosimilars in a...more

Goodwin

FDA Releases Five-Year Plans for User Fee Programs

Goodwin on

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

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