Shots: The EC’s approval is based on the REFLECTIONS B3281006 study assessing efficacy, safety and immunogenicity, PK/PD of Ruxience that demonstrated the bio-similarity of Ruxience of its reference product, MabThera […]readmore
Tags : Ruxience
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, […]readmore
Shots: The EMA’s CHMP has adopted a positive opinion, recommending MAA for Ruxience, a biosimilar referencing MabThera The regulatory submission is based on REFLECTIONS B3281006 study assessing the efficacy, safety, […]readmore
Shots: The approval is based on REFLECTIONS B3281006 study results assessing Ruxience vs reference product, Rituxan (rituximab) in patients with CD20-positive, low tumor burden follicular lymphoma The REFLECTIONS B3281006 study […]readmore