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# Companies on Bispecific Antibody Development
- URL: https://www.fdaweb.com/companies-on-bispecific-antibody-development/
- Published: 2019-06-19T12:00:00.000Z
- Updated: 2026-09-15T01:33:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144374

AstraZeneca says it supports harmonization of requirements wherever possible and encourages FDA to take the concepts in its draft guidance on bispecific antibody development forward for future updates to harmonized standards as applicable. In a [letter](https://www.regulations.gov/document?D=FDA-2019-D-0621-0006&ref=fdaweb.com) commenting on the draft guidance, AZ says that if a comparative clinical study is requested, the company recommends that adequate guidance on study design be provided to sponsors as early as possible in the drug development program.

Letters containing charts with specific line-by-line technical comments were submitted by [Pfizer](https://www.regulations.gov/document?D=FDA-2019-D-0621-0005&ref=fdaweb.com), [Janssen](https://www.regulations.gov/document?D=FDA-2019-D-0621-0008&ref=fdaweb.com), [Novartis](https://www.regulations.gov/document?D=FDA-2019-D-0621-0007&ref=fdaweb.com), and [Lilly](https://www.regulations.gov/document?D=FDA-2019-D-0621-0009&ref=fdaweb.com).