Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.

Background: Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2).

Lanthanoid Rhenium Aluminides with a High Content of Aluminum: LnRe(2)Al(10) (Ln = Ho-Lu) with a New Structure Type and NdRe(2)Al(10) with CaCr(2)Al(10)-Type Structure.

The title compounds were obtained by reaction of the elemental components with an excess of aluminum after dissolving the matrix in hydrochloric acid. The compounds LnRe(2)Al(10) (Ln = Ho-Lu) crystallize with a new structure type, which was determined from single-crystal X-ray data of LuRe(2)Al(10): Cmcm, a = 929.1(1) pm, b = 1027.