BioSpace News Archive

Thanks in part to the revolution cell therapy brought to treating blood cancers, the modality is now showing promise in some autoimmune applications. This expansion is poised to yield even wider benefits.

Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.

The petition requests that the FDA broaden the scientific principles supporting generics and biosimilars to encompass all eligible FDA-approved drugs and biological products. The initiatives has the potential to foster competition for some of the most expensive therapies globally once patent and exclusivity protections expire, thereby eliminating barriers to market entry.