Jun 3, 2026· Comment from Association for Accessible Medicines / Biosimilar Council· FDA-2011-D-0611-0101
AAM/Biosimilar Council Comments
FDANonrulemakingFDA-2011-D-0611
Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
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Last modified
Jun 11, 2026
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closed 78d ago
Association for Accessible Medicines filings
3
Activity
Association for Accessible Medicines filed 3 comments on this docket between Feb 12, 2019 and Jun 3, 2026. 2 other organizations filed here. The comment window closed 78d ago.
What Association for Accessible Medicines filed (3)
Jan 19, 2021· Comment from Association for Accessible Medicines· FDA-2011-D-0611-0084
Filed on regulations.gov — full text not in the inline record.
Feb 12, 2019· Comment from Association for Accessible Medicines· FDA-2011-D-0611-0072
The Association for Accessible Medicines and the Biosimilars Council (collectively referred to as AAM) are pleased to provide comments on the Food and Drug Administrations (FDAs or the Agencys) Question and Answer guidance documents regarding biosimilar development under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). AAM is submitting consolidated comments that address both FDAs draft guidance entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Draft Q&A Guidance) and FDAs final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act (Final Q&A Guidance).
Abstract
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View on regulations.gov →Co-filers (2)
See everyone who commented →- Association for Accessible MedicinesTHIS ORG3 filings · confidence 97%
- National Association of Chain Drug Storestrade assoc.1 filing · confidence 97%
- Parenteral Drug Associationtrade assoc.1 filing · confidence 97%