Anaphylaxis and the inclusion of polysorbates in biotherapeutics
Both unwanted immunogenicity and anaphylaxis comprise major components of safety assessment, however, few if any attempts are made to differentiate drug-related from excipient-related anaphylaxis. Replacement of anaphylactogenic and immunogenic functional excipients with equally effective but safer...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
International Pharmaceutical Excipients Council
2017-12-01
|
| Series: | Journal of Excipients and Food Chemicals |
| Online Access: | https://jefc.scholasticahq.com/article/3115-anaphylaxis-and-the-inclusion-of-polysorbates-in-biotherapeutics |
| Summary: | Both unwanted immunogenicity and anaphylaxis comprise major components of safety assessment, however, few if any attempts are made to differentiate drug-related from excipient-related anaphylaxis. Replacement of anaphylactogenic and immunogenic functional excipients with equally effective but safer alternatives will allow biotherapeutic developers to differentiate their biotherapeutic, biosimilar, or biobetter product from the large number of nearly identical competitor products, simultaneously providing a substantial commercial benefit as well as critical clinical benefits for all concerned - patients, physicians, and third party payers. |
|---|---|
| ISSN: | 2150-2668 |