Rituximab 500 mg/50mL
concentrate for solution for infusion(Sandoz GmbH), BT-ON007

WHOPAR part 7

October 2020

Steps before prequalificationI

BACKGROUND INFORMATION ON THE PROCEDURE

1. Submission of the dossier
The company Sandoz GmbH submitted in 2018 an application for Rixathon 1 500mg/50mL concentrate
for solution for infusion, to be assessed with the aim of including Rixathon in the list of prequalified
medicinal products for the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukaemia
and follicular lymphoma.
Rixathon was assessed according to the WHO Pilot Procedure for Prequalification of Biotherapeutic
Products: rituximab and trastuzumab 2 and relevant applicable guidelines by the team of WHO assessors.
The assessors are senior experts, mainly from national authorities, invited by WHO to participate in theprequalification assessment process.
The prequalification of this product by the WHO Prequalification of Medicines Programme is based on
the approval by a stringent regulatory authority (SRA), namely the “European Medicines Agency”(EMA; http://www.ema.europa.eu/ema/) in line with the applicable guidelines2.
Hence, no assessment of the data underlying this approval has been undertaken within the WHO
Prequalification Team: Medicines (PQTm). However, according to the above-mentioned guideline
WHO verified that the product, and in particular composition/formulation, strength, manufacturing,specifications, packaging, product information, will, at the time of submission and after prequalification,in all respects be the same as the product registered with the reference SRA (“verification”).
Furthermore, WHO requested additional data for the safe use of the product in regions relevant forprequalified products and this information is included in the WHOPAR (part 6b). In order to safeguard
product quality throughout its entire intended shelf‐life, WHO assessed the evidences to verify theadherence to the principles outlined in the most recent version of the WHO guidelines on theinternational packaging and shipping of vaccines, also partially applicable to other biotherapeutic
products 3, to demonstrate suitability of the packaging to regions outside of climatic zone II. The WHO
assessment included the packaging procedures for international shipments and the validation protocols
and reports of the shipping boxes used for supply of the prequalified product.
Based on the data submitted the team of assessors advised that Rixathon is included in the list ofprequalified medicinal products. Rixathon was listed on 17 September 20202.
Licensing status:
Rixathon has been licensed / registered in the European Union.
2. Steps taken in the evaluation of the productOct 2018
Jul 2019
Sep 2019

The applicant submitted the dossier.
The assessment team reviewed the submitted data and accepted the dossier forassessment.
The assessment team reviewed the submitted document for the verification, quality
and pharmacovigilance data and further information was requested.

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
Throughout this WHOPAR the proprietary name is given as an example only.
2
https://www.who.int/medicines/regulation/biotherapeutic_products/en/3
https://www.who.int/immunization_standards/vaccine_quality/vaccines_packaging_guidelines2019/en/
1

Rituximab 500 mg/50mL
concentrate for solution for infusion(Sandoz GmbH), BT-ON007

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IIWHOPAR part 7

October 2020

The applicant’s response letter was received.
The assessment team reviewed the submitted data and further data was requested on
quality and pharmacovigilance. The verification was found to be in compliance withWHO requirements
The applicant’s response letter was received.
The assessment team reviewed the submitted data and further data was requested on
pharmacovigilance. The quality was found to be in compliance with WHO
requirements
The applicant’s response letter was received.
The assessment team reviewed the submitted data and further data was requested on
pharmacovigilance.
The applicant’s response letter was received.
The assessment team reviewed the submitted data. Pharmacovigilance data were
found to be in compliance with WHO requirements
Rixathon 500mg/50mL concentrate for solution for infusion was included in the listof prequalified medicinal products.

GENERAL CONDITIONS FOR THE PREQUALIFICATION

1. Manufacturer, Commitments and Inspection status
Name and address of the manufacturer(s) of the biological active substance(s)Sandoz GmbH Schaftenau
Biochemiestr. 106336 Langkampfen
AUSTRIA
Novartis Manufacturing GmbH
Emil-von-Behring-Straße 76
35041 Marburg
Germany
Boehringer Ingelheim Pharma GmbH & Co. KG
Birkendorfer Straße 6588397 Biberach an der Riss
GermanyName and address of the manufacturer(s) responsible for batch release
Sandoz GmbH Schaftenau
Biochemiestr. 106336 Langkampfen
AUSTRIALek Pharmaceuticals d.d. Ljubljana
Verovškova 571526 Ljubljana
Slovenia

Rituximab 500 mg/50mL
concentrate for solution for infusion(Sandoz GmbH), BT-ON007

WHOPAR part 7

October 2020

Commitments for Prequalification
The Applicant committed to submit to WHO following each marketing authorization, a brief discussion
on how the Applicant has addressed, after product prequalification, any potential differences inhealthcare settings, compared to SRAs, that have required a revision of the adequacy of the safetyconcerns, pharmacovigilance activities, risk minimisation measures and/or traceability of the product.
Inspection status
The sites are inspected by a stringent regulatory authority.