Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure IMATINIB TEVA UK 100 MG FILM-COATED TABLETS IMATINIB TEVA UK 400 MG FILM-COATED TABLETS (imatinib mesilate) Procedure No: UK Licence No: PL 00289/ Teva UK Limited

2 LAY SUMMARY Imatinib Teva UK 100 mg film-coated tablets Imatinib Teva UK 400 mg film-coated tablets (imatinib mesilate) This is a summary of the public assessment report (PAR) for Imatinib Teva UK 100 mg film-coated tablets (PL 00289/1516) and Imatinib Teva UK 400 mg film-coated tablets (PL 00289/1517). It explains how Imatinib Teva UK 100 mg and 400 mg film-coated tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Imatinib Teva UK 100 mg and 400 mg film-coated tablets. For practical information about using Imatinib Teva UK 100 mg and 400 mg film-coated tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are Imatinib Teva UK 100 mg and 400 mg film-coated tablets and what are they used for? Imatinib Teva UK 100 mg and 400 mg film-coated tablets are generic medicines. This means that Imatinib Teva UK 100 mg and 400 mg film-coated tablets are similar to reference medicines already authorised in the European Union (EU) called Glivec 100 mg hard capsules and Glivec 400 mg filmcoated tablets. Imatinib Teva UK 100 mg and 400 mg film-coated tablets are used in adults to treat a late stage of Chronic Myeloid Leukaemia called blast crisis. In children, however, it may be used to treat all stages of the illness. How are Imatinib Teva UK 100 mg and 400 mg film-coated tablets used? In adults, the usual starting dose is 600 mg to be taken once a day. A higher or lower dose may be prescribed depending on how the patient responds to the treatment. If the daily dose is 800 mg, it should be split into two administrations (half in the morning and half in the evening). In children and adolescents the amount of imatinib given will depend on the child s condition, body weight and height. The total daily dose in children must not exceed 800 mg. The treatment can either be given as a once-daily dose or the daily dose can be split into two administrations (half in the morning and half in the evening). These medicines can only be obtained with a prescription. How do Imatinib Teva UK 100 mg and 400 mg film-coated tablets work? Imatinib Teva UK 100 mg and 400 mg film-coated tablets contain an active ingredient called imatinib. These medicines work by inhibiting the growth of abnormal cells in chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control. How have Imatinib Teva UK 100 mg and 400 mg film-coated tablets been studied? Because Imatinib Teva UK 100 mg and 400 mg film-coated tablets are generic medicines, studies in patients have been limited to tests to determine that they are bioequivalent to the reference medicines, Glivec 100 mg hard capsules and Glivec 400 mg film-coated tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the benefits and risks of Imatinib Teva UK 100 mg and 400 mg film-coated tablets? Because Imatinib Teva UK 100 mg and 400 mg film-coated tablets are generic medicines that are bioequivalent to the reference medicines, their benefits and risks are taken as being the same as the 2

3 reference medicines. Why are Imatinib Teva UK 100 mg and 400 mg film-coated tablets approved? It was concluded that, in accordance with EU requirements, Imatinib Teva UK 100 mg and 400 mg filmcoated tablets have been shown to have comparable quality and to be bioequivalent to Glivec 100 mg hard capsules and Glivec 400 mg film-coated tablets. Therefore, the view was that, as for Glivec 100 mg hard capsules and Glivec 400 mg film-coated tablets, the benefit outweighs the identified risk. What measures are being taken to ensure the safe and effective use of Imatinib Teva UK 100 mg and 400 mg film-coated tablets? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Imatinib Teva UK 100 mg and 400 mg film-coated tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Imatinib Teva UK 100 mg and 400 mg film-coated tablets Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Germany, Estonia, Greece, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia and the UK agreed to grant Marketing Authorisations for Imatinib Teva UK 100 mg and 400 mg film-coated tablets on 13 June Marketing Authorisations were granted in the UK on 19 December The full PAR for Imatinib Teva UK 100 mg and 400 mg film-coated tablets follows this summary. For more information about treatment with Imatinib Teva UK 100 mg and 400 mg film-coated tablets, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in January

4 TABLE OF CONTENTS Module 1: Information about initial procedure Page 5 Module 2: Summary of Product Characteristics Page 6 Module 3: Patient Information Leaflet Page 7 Module 4: Labelling Page 8 Module 5: Scientific discussion during initial procedure Page 12 I II III III.1 III.2 III.3 IV Introduction About the product Scientific overview and discussion Quality aspects Non-clinical aspects Clinical aspects Overall conclusion and benefit-risk assessment Module 6: Steps taken after initial procedure Page 19 4

5 Module 1 Information about initial procedure Product Name Imatinib Teva UK 100 mg film-coated tablets Imatinib Teva UK 400 mg film-coated tablets Type of Application Generic, Article 10(1) Active Substances Form Strength MA Holder Reference Member State (RMS) Imatinib mesilate Film-coated tablets 100 mg and 400 mg Teva UK Limited, Brampton road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom UK Concerned Member States (CMS) Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Germany, Estonia, Greece, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia and Slovakia Procedure Number UK/H/2678/001/DC UK/H/2678/002/DC Timetable Day June

6 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) for products that have been granted Marketing Authorisations at a national level are available on the MHRA website. 6

7 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU the Patient Information Leaflets for products that are granted Marketing Authorisations at a national level are available on the MHRA website. 7

8 Module 4 Labelling The following text is the approved label text for Imatinib Teva UK 100 mg film-coated tablets (PL 00289/1516). No label mock-ups have been provided for this product. In accordance with medicines legislation, the product shall not be marketed in the UK until approval of the label mock-ups has been obtained. 8

9 9

10 The following text is the approved label text for Imatinib Teva UK 400 mg film-coated tablets (PL 00289/1517). No label mock-ups have been provided for this product. In accordance with medicines legislation, the product shall not be marketed in the UK until approval of the label mock-ups has been obtained. 10

11 11

12 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Member States considered that the applications for Imatinib Teva UK 100 mg and 400 mg film-coated tablets (PL 00289/ ; ) could be approved. The applications were submitted via the Decentralised Procedure, with the UK as Reference Member State (RMS), and Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Germany, Estonia, Greece, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia and Slovakia as Concerned Member States (CMS). These products can only be obtained with a prescription (legal classification POM). These applications were made under the Decentralised Procedure (DCP), according to Article 10(1) of Directive 2001/83/EC, as amended, claiming to be generic medicinal products of the originator product Glivec 100 mg hard capsules (Novartis Europharm Limited), which was initially granted a Marketing Authorisation in the EU, via the Centralised Procedure, on 07 November The reference product for the 400 mg strength product is Glivec 400 mg film-coated tablets (Novartis Europharm Limited), which was granted a Marketing Authorisation in the EU, via the Centralised Procedure, on 11 November The reference product used in the bioequivalence study is Glivec 400 mg film-coated tablets (Novartis Europharm Limited). Imatinib Teva UK 100 mg and 400 mg film-coated tablets are indicated for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome (bcr abl) positive (Ph+) chronic myeloid leukaemia (CML), for whom bone marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+ CML in chronic phase after failure of interferon alpha therapy or in accelerated phase; and for adult and paediatric patients with Ph+ CML in blast crisis. These products contain the active substance imatinib. Imatinib is a protein-tyrosine kinase inhibitor which targets the Bcr-Abl tyrosine kinase, resulting in inhibition of proliferation and induction of apoptosis. Imatinib also inhibits the receptor tyrosine kinases for several receptor tyrosine kinases including Kit, the receptor for stem cell factor (SCF), the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta). Imatinib can also inhibit cellular events mediated by activation of these receptor kinases. No non-clinical studies and, with the exception of the bioequivalence study, no new clinical studies were conducted, which is acceptable given that these applications were based on being generic medicinal products of an originator product that has been licensed for over 10 years. A bioequivalence study was performed, which compared the pharmacokinetics of the test product Imatinib TEVA 400 mg film-coated tablets to those of the reference product Glivec 400 mg film-coated tablets (Novartis Europharm Limited). The bioequivalence study was carried out in accordance with Good Clinical Practice (GCP). The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for this product type at all sites responsible for the manufacture, assembly and batch release of these products. The RMS and CMS considered that the applications could be approved at the end of procedure on 13 June After a subsequent national phase, marketing authorisations were granted in the UK on 19 December

13 II. ABOUT THE PRODUCT Name of the product in the Reference Member State Name(s) of the active substance(s) (INN) Pharmacotherapeutic classification (ATC code) Pharmaceutical form and strength(s) Reference numbers for the Decentralised Procedure Reference Member State Imatinib Teva UK 100 mg film-coated tablets Imatinib Teva UK 400 mg film-coated tablets Imatinib mesilate Antineoplastic agents; protein kinase inhibitor (L01XE01) Film-coated tablets 100 mg and 400 mg UK/H/2678/001/DC UK/H/2678/002/DC UK Member States concerned Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Germany, Estonia, Greece, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia and Slovakia Marketing Authorisation Number(s) PL 00289/1516 PL 00289/1517 Name and address of the authorisation holder Teva UK Limited, Brampton road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom 13

14 III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS S. Active substance Imatinib mesilate rinn: Imatinib mesilate Chemical name: 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2- pyrimidinyl]aminophenyl]benzamide methanesulfonate salt Structure: Molecular formula: C 29 H 31 N 7 O_CH 4 SO 3 Molecular weight: (mesylate); (free base) Appearance: Off-white or slightly yellowish crystalline powder Solubility: Freely soluble in various aqueous buffers, soluble in methanol and slightly soluble in ethanol An Active Substance Master File (ASMF) has been provided by the active substance manufacturer, covering the manufacture and control of the active substance imatinib mesilate. Synthesis of the drug substance from the designated starting materials has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents and these are supported by relevant certificates of analysis. Appropriate proof-of-structure data have been supplied for the active substance. All potential known impurities have been identified and characterised. An appropriate specification is provided for the active substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Satisfactory Certificates of Analysis have been provided for all working standards. Batch analysis data are provided and comply with the proposed specification. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with food. Appropriate stability data have been generated to support a suitable retest period when stored in the proposed packaging. P. Medicinal Product Other Ingredients Other ingredients consist of the pharmaceutical excipients, as follows: Tablet core: Mannitol, crospovidone, sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silica Film-coating: 14

15 Macrogol poly(vinyl alcohol) grafted copolymer, poly(vinyl alcohol), silica, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) With the exception of the Macrogol poly(vinyl alcohol) grafted copolymer and the yellow and red iron oxides, which comply with suitable in-house specifications, all excipients used comply with their respective European Pharmacopoeia monographs. None of the excipients are sourced from animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of this product. Pharmaceutical Development The objective of the development programme was to formulate globally acceptable and stable products that could be considered generic medicinal products of the currently licensed products of Glivec 100 mg hard capsules and Glivec 400 mg film-coated tablets (Novartis Europharm Limited). A satisfactory account of the pharmaceutical development has been provided. Manufacturing Process Satisfactory batch formulae have been provided for the manufacture of the products, along with an appropriate account of the manufacturing process. Suitable in-process controls are in place to ensure the quality of the finished product. Process validation has been carried out on two commercial-scale batches of each strength of finished product. The results are satisfactory. Finished Product Specification The finished product specifications proposed are acceptable. Test methods have been described that have been adequately validated. Batch data have been provided that comply with the release specifications. Certificates of Analysis have been provided for all working standards used. Container-Closure System The finished product is presented in the following packaging and pack sizes: Polyvinyl chloride/polyethylene/polyvinylidene chloride/aluminium blisters in pack sizes of 60 or 120 film-coated tablets Oriented polyamide/polyvinyl chloride/aluminium perforated unit dose blisters in pack sizes of 20 x 1, 60 x 1, 120 x 1 and 180 x1 film-coated tablets Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. All primary packaging complies with the current European regulations concerning materials in contact with food. Stability of the product Stability studies were performed, in accordance with current guidelines, on batches of finished product manufactured by the finished product manufacturer and packed in the packaging proposed for marketing. The results from these studies support a shelf-life of 2 years with no special storage conditions. Bioequivalence/bioavailability A bioequivalence study was performed, which compared the pharmacokinetics of the test product Imatinib TEVA UK 400 mg film-coated tablets to those of the reference product Glivec 400 mg filmcoated tablets (Novartis Europharm Limited). 15

16 Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels The SmPCs, PILs and text versions of the labels are acceptable from a pharmaceutical perspective. The results of consultations with target patient groups ( user testing ), in accordance with Article 59 of Council Directive 2001/83/EC (as amended) for the package leaflets for Imatinib Teva UK 100 mg and 400 mg film-coated tablets were provided. The results indicate that the package leaflets are wellstructured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that they contain. Marketing Authorisation Application (MAA) form The MAA forms are satisfactory from a pharmaceutical perspective. Quality Overall Summary (Expert report) The pharmaceutical expert report has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical dossier. Conclusion The grant of Marketing Authorisations is recommended. III.2 NON-CLINICAL ASPECTS As the pharmacodynamic, pharmacokinetic and toxicological properties of imatinib mesilate are well-known, no further non-clinical studies are required and none have been provided. The applicant s non-clinical expert report has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the product s pharmacology and toxicology. Suitable justification has been provided for the non-submission of an environmental risk assessment. As this product is intended for generic substitution with products that are currently marketed, no increase in environmental burden is expected. There are no objections to the approval of these products from a non-clinical viewpoint. III.3 CLINICAL ASPECTS Pharmacokinetics In support of these applications, the Marketing Authorisation Holder has submitted the following bioequivalence study: A single-dose, randomised, two-period, two-sequence, two-treatment, crossover study to compare the pharmacokinetic profile of Imatinib Teva UK 400 mg film-coated tablets (Test; A) with Glivec 400 mg film-coated tablets (Reference; B) in healthy adult subjects, under fed conditions. Study participants were given each treatment after a high fat, high calorie breakfast and with 240 ml of room temperature water. Blood samples were collected for the measurement of pharmacokinetic parameters pre-dose and up to 48 hours post dose. Each treatment regimen was separated by a 7-day washout period. The main pharmacokinetic results are presented in the table below: 16

17 Compared with the reference product, the 90 % confidence intervals for the test product are within % for AUC and Cmax. Imatinib Teva UK 400 mg film-coated tablets can, therefore, be considered to be bioequivalent with Glivec 400 mg film-coated tablets. As these products meet the bio-waiver criteria specified in the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr**), the results and conclusions of the bioequivalence study on the 400 mg strength can be extrapolated to the 100 mg strength film-coated tablets. Efficacy No new data on efficacy have been submitted and none are required for this type of application. Safety With the exception of the data submitted during the bioequivalence study, no new safety data were submitted and none were required. No new or unexpected safety issues were raised by the bioequivalence data. SmPC, PIL and Labels The SmPCs, PILs and text versions of the labels are acceptable from a clinical perspective. Pharmacovigilance System and Risk Management Plan The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. Suitable justification has been provided for not submitting a risk management plan for this product. 17

18 Clinical Expert Report The clinical expert report has been written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. Conclusion The grant of Marketing Authorisations is recommended. IV OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY The important quality characteristics of Imatinib Teva UK 100 mg and 400 mg film-coated tablets are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit-risk balance. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. CLINICAL Bioequivalence has been demonstrated between the applicant s products and the reference products. No new or unexpected safety concerns arose from these applications. The SmPCs, PILs and text versions of labelling are satisfactory and consistent with those for the reference products. BENEFIT-RISK ASSESSMENT The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with imatinib mesilate is considered to have demonstrated the therapeutic value of the compound. The benefit-risk assessment is, therefore, considered to be positive. 18

19 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 19

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