Biosimilarity to Reference Rituximab

RUXIENCE® SUCCESSFULLY DEMONSTRATED BIOSIMILARITY TO REFERENCE RITUXIMAB2-5

RUXIENCE® was licensed by the EMA based on the totality of evidence supporting high similarity to reference rituximab2-5

The totality of evidence supports comparability to reference rituximab2-5

 

REFERENCES

  1. RUXIENCE® Summary of Product Characteristics.
  2. Data on file. Rituximab clinical overview. Pfizer Inc.
  3. Yin D, Becker J-C, Melia LA. A Phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis with active disease in TNF failures (REFLECTIONS B328-01).  Poster FRI0309 presented at: European League Against Rheumatism (EULAR) 2014 Annual Congress; June 11-14, 2014; Paris, France. 
  4. Ryan AM, Sokolowski SA, Ng C-K, et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®). Toxicol Pathol. 2014;42(7):1069-1081. 
  5. Karnik S, Thompson MS, DeGruttola H, et al. Characterization and comparison of PF-05280586, a proposed rituximab biosimilar, to the licensed product. Poster M1038 presented at: American Association of Pharmaceutical Scientists-National Biotech Conference; May 20-22, 2013; San Diego, CA. 
  6. Data on file. Pfizer oncology strategy and pipeline. Pfizer Inc.
  7. RETACRIT® Summary of Product Characteristics.
  8. TRAZIMERA® Summary of Product Characteristics. 
  9. NIVESTIM® Summary of Product Characteristics.
  10. ZIRABEV®  Summary of Product Characteristics.

RUXIENCE® SUCCESSFULLY DEMONSTRATED BIOSIMILARITY TO REFERENCE RITUXIMAB2-5

RUXIENCE® was licensed by the EMA based on the totality of evidence supporting high similarity to reference rituximab2-5

RUXIENCE® IS HIGHLY SIMILAR IN STRUCTURE AND FUNCTION TO REFERENCE RITUXIMAB5*

Structural similarity: identical primary amino acid sequence2 Peptide mapping data supported identical primary amino acid sequence for RUXIENCE® and reference rituximab5†

Peptide mapping data supported identical primary amino acid sequence for RUXIENCE® and reference rituximab5†

rux_peptide

*RUXIENCE® was highly similar to reference rituximab in structure and function, as determined by state-of-the-art analysis. There was little residual uncertainty after analytical and biological characterization.

This is one of multiple tests conducted to demonstrate high similarity. In addition, primary structure, post-translational modifications, molecular mass, protein concentration, purity, charge heterogeneity, higher order structure, and drug product stability (comparative forced degradation) all supported high similarity (not shown here).

Functional similarity: representative examples of dose-response curves from development program that supported highly similar CDC and ADCC activity5

biosimilarity-reference-rituximab1_0

CDC=complement-dependent cytotoxicity. ADCC=antibody-dependent cell-mediated cytotoxicity.

 

REFERENCES

  1. RUXIENCE® Summary of Product Characteristics.
  2. Data on file. Rituximab clinical overview. Pfizer Inc.
  3. Yin D, Becker J-C, Melia LA. A Phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis with active disease in TNF failures (REFLECTIONS B328-01). Poster FRI0309 presented at: European League Against Rheumatism (EULAR) 2014 Annual Congress; June 11-14, 2014; Paris, France. 
  4. Ryan AM, Sokolowski SA, Ng C-K, et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®). Toxicol Pathol. 2014;42(7):1069-1081. 
  5. Karnik S, Thompson MS, DeGruttola H, et al. Characterization and comparison of PF-05280586, a proposed rituximab biosimilar, to the licensed product. Poster M1038 presented at: American Association of Pharmaceutical Scientists-National Biotech Conference; May 20-22, 2013; San Diego, CA. 
  6. Data on file. Pfizer oncology strategy and pipeline. Pfizer Inc.
  7. RETACRIT® Summary of Product Characteristics.
  8. TRAZIMERA® Summary of Product Characteristics.
  9. NIVESTIM® Summary of Product Characteristics.
  10. ZIRABEV® Summary of Product Characteristics.

RUXIENCE® SUCCESSFULLY DEMONSTRATED BIOSIMILARITY TO REFERENCE RITUXIMAB2-5

RUXIENCE® was licensed by the EMA based on the totality of evidence supporting high similarity to reference rituximab2-5

Similar PK profile to reference rituximab in healthy subjects with RA in a 3-arm study3

PK profiles following two 1000-mg IV doses (on study days 1 and 15) of RUXIENCE® or reference rituximab in patients with rheumatoid arthritis receiving background therapy with methotrexate3

rux_pk_profile

The 90% confidence intervals for the test-to-reference ratios of Cmax, AUC0-t, AUC0-2wk, and AUC0-∞ were within the acceptance window of 80% to 125% for pairwise comparisons of RUXIENCE® to reference rituximab - US, RUXIENCE® to reference rituximab - EU, and reference rituximab - EU to reference rituximab - US3

rux_b-cell

 

REFERENCES

  1. RUXIENCE® Summary of Product Characteristics. 
  2. Data on file. Rituximab clinical overview. Pfizer Inc.
  3. Yin D, Becker J-C, Melia LA. A Phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis with active disease in TNF failures (REFLECTIONS B328-01). Poster FRI0309 presented at: European League Against Rheumatism (EULAR) 2014 Annual Congress; June 11-14, 2014; Paris, France. 
  4. Ryan AM, Sokolowski SA, Ng C-K, et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®). Toxicol Pathol. 2014;42(7):1069-1081. 
  5. Karnik S, Thompson MS, DeGruttola H, et al. Characterization and comparison of PF-05280586, a proposed rituximab biosimilar, to the licensed product. Poster M1038 presented at: American Association of Pharmaceutical Scientists-National Biotech Conference; May 20-22, 2013; San Diego, CA. 
  6. Data on file. Pfizer oncology strategy and pipeline. Pfizer Inc.
  7. RETACRIT® Summary of Product Characteristics. 
  8. TRAZIMERA® Summary of Product Characteristics.
  9. NIVESTIM® Summary of Product Characteristics.
  10. ZIRABEV® Summary of Product Characteristics.

RUXIENCE® SUCCESSFULLY DEMONSTRATED BIOSIMILARITY TO REFERENCE RITUXIMAB2-5

RUXIENCE® was licensed by the EMA based on the totality of evidence supporting high similarity to reference rituximab2-5

RUXIENCE® IS APPROVED ACROSS ALL ELIGIBLE INDICATIONS OF REFERENCE RITUXIMAB THROUGH THE PROCESS OF EXTRAPOLATION2

Scientific justification supports extrapolation of all eligible indications of reference rituximab to RUXIENCE®2

clinical_studies

 

REFERENCES

  1. RUXIENCE® Summary of Product Characteristics.
  2. Data on file. Rituximab clinical overview. Pfizer Inc.
  3. Yin D, Becker J-C, Melia LA. A Phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis with active disease in TNF failures (REFLECTIONS B328-01). Poster FRI0309 presented at: European League Against Rheumatism (EULAR) 2014 Annual Congress; June 11-14, 2014; Paris, France. 
  4. Ryan AM, Sokolowski SA, Ng C-K, et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®). Toxicol Pathol. 2014;42(7):1069-1081. 
  5. Karnik S, Thompson MS, DeGruttola H, et al. Characterization and comparison of PF-05280586, a proposed rituximab biosimilar, to the licensed product. Poster M1038 presented at: American Association of Pharmaceutical Scientists-National Biotech Conference; May 20-22, 2013; San Diego, CA. 
  6. Data on file. Pfizer oncology strategy and pipeline. Pfizer Inc.
  7. RETACRIT® Summary of Product Characteristics.
  8. TRAZIMERA® Summary of Product Characteristics. 
  9. NIVESTIM® Summary of Product Characteristics.
  10. ZIRABEV® Summary of Product Characteristics.

 

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SPC for how to report adverse reactions.

Legal Category: POM S1A

PP-RIT-IRL-0038. Preparation Date: April 2022