Glossary
Q-Sphera |
Q Chip’s novel proprietary encapsulation technology for peptide and protein delivery. |
Peptide |
Peptide chains that are short enough to be made synthetically from the constituent amino acids. |
Protein |
Polypeptide molecules produced using biological systems. |
Biopharmaceuticals / Biotherapies |
Medical drugs produced using biotechnology. These are proteins (including antibodies), peptides, and nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic purposes. |
Biogenerics |
Generic versions of peptide biopharmaceuticals. These are classed as drugs rather than biologics and are regulated via the ANDA pathway with the pivotal clinical study designed to show bioequivalence to the approved innovator product. |
Biosimilars |
A new type of biogeneric biopharmaceutical approval in the EU (pertaining to biopharmaceuticals manufactured using biological systems). |
Follow-on-biologics (FOBs) |
FDA equivalent of Biosimilar, regulatory track does not yet exist (pertaining to biopharmaceuticals manufactured using biological systems). |
Biobetters |
Newer versions of expired-patent biopharmaceuticals that have therapeutic improvements over innovator product ( Better efficacy, administration, or side-effect profile). |
