Shots:

• The 1st P-I study evaluates MSB11456 as SC formulation vs US-Actemra/EU-RoActemra & 2nd P-I study evaluate MSB11456 vs Actemra as IV formulation in patients with moderately to severely active RA
• Both studies met all 1EPs & 2EPs i.e.- PK equivalence demonstrated in all 3 treatment groups & no differences in safety and immunogenicity were identified. The first P-I study also showed the similarity b/w MSB11456 & Actemra/RoActemra at PD level
• The company has completed the patient enrolment in the P-III study of MSB11456 (biosimilar- tocilizumab) vs RoActemra for patients with the same indications across EU

  | Ref: Fresenius Kabi:  | Image:  Fresenius Kabi