Recommended Comparator Products: Medicines for HIV/AIDS and Related Diseases

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Beatrix Cross
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1 Medicines for HIV/AIDS and Related Diseases Comparator products should be purchased from a well-regulated market with a stringent regulatory authority. 1 Invited medicinal products Abacavir, 60 mg, 300 mg and 600 mg tablet, 20 mg/ml oral liquid Atazanavir, 150 mg and 300 mg capsule Darunavir, 400 mg, 600 mg and 800 mg tablet Didanosine, 125 mg, 200 mg, 250 mg and 400 mg enteric coated capsule, 25 and 50 mg buffered/chewable tablet Antiretrovirals as single-ingredient formulations Recommended comparator product (strength, manufacturer) Ziagen (300 mg tablet, 20 mg/ml oral solution, Reyataz (150 mg and 300 mg capsule, Bristol-Myers Squibb) Prezista (400 mg, 600 mg and 800 mg tablet, Janssen- Cilag/Tibotec) Videx EC (125 mg, 200 mg, 250 mg and 400 mg capsule with enteric coated pellets, Videx 25 and 50 mg buffered tablet, Bristol-Myers Squibb) Dolutegravir, 50 mg tablet Efavirenz, 100 mg, 200 mg and 600 mg tablet Emtricitabine, 200 mg capsule, 10 mg/ml oral liquid Etravirine, 25 mg and 100 mg tablet Lamivudine, 30 mg, 150 mg and 300 mg tablet, 10 mg/ml oral liquid Nevirapine, 20 mg, 50 mg, 100 mg and 200 mg tablet, 6 mg granules, 10 mg/ml oral liquid Raltegravir, 400 mg tablet Ritonavir, 100 mg capsule, 25 mg (heat stable) tablet and 100 mg (heat stable) tablet Tivicay 50 mg tablet, ViiV Healthcare Sustiva or Stocrin ( 100 mg and 200 mg capsule, 600 mg tablet Bristol-Myers Squibb or Merck) Emtriva (200 mg capsule, 10 mg/ml oral solution, Gilead) Intelence (100 mg tablet, Tibotec) Epivir (150 mg and 300 mg tablet, 10 mg/ml oral solution, Viramune (200 mg tablet, 10 mg/ml oral suspension, Boehringer Ingelheim) Isentress (400 mg tablet, Merck Sharpe Dohme) Norvir (100 mg capsule, AbbVie Ltd) Norvir (100 mg (heat stable) tablet, AbbVie Ltd) 1 A regulatory authority that is: a) a member of ICH prior to 23 October 2015, namely: the US Food and Drug Administration, the European Commission and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or b) an ICH observer prior to 23 October 2015, namely: the European Free Trade Association, as represented by Swissmedic and Health Canada; or c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein and Norway. Medicines for HIV/AIDS and Related Diseases 1

2 Stavudine, 30 mg capsule Tenofovir disoproxil fumarate, 300 mg tablet Zidovudine, 60 mg and 300 mg tablet, 250 mg capsule, 12 mg granules, 10 mg/ml oral liquid Zerit (30 mg capsule, Bristol-Myers Squibb) Viread (300 mg tablet, 40 mg/scoop full powder for oral use, Gilead) Retrovir (300 mg tablet, 250 mg capsule, 10 mg/ml syrup, Fixed-dose combination products of antiretrovirals Lamivudine 150 mg + Zidovudine 300 mg tablet, 150 mg mg tablet, 30 mg + 60 mg tablet Lamivudine 300 mg + Abacavir 600 mg (scored) tablet, 30 mg + 60 mg (scored) tablet Lamivudine 30 mg + Zidovudine 60 mg + Abacavir 60 mg (scored) tablet, 150 mg mg mg tablet Lopinavir 100 mg + Ritonavir 25 mg (heat-stable) tablet, 200 mg + 50 mg (heat-stable) tablet and 40 mg + 10 mg (heat-stable) granules/sachet Tenofovir 300 mg + Emtricitabine 200 mg tablet Tenofovir 300mg + Efavirenz 600 mg + Emtricitabine 200 mg tablet Combivir (150mg+300 mg tablet, Kivexa or Epzicom (300mg+600mg tablet, Trizivir (150mg+300mg+300mg tablet, Kaletra (100mg+25mg and 200mg+50mg tablet, Abbott Laboratories) Truvada (300mg+200mg tablet, Gilead) Atripla (300mg+600mg+200mg tablet, Gilead) For other invited fixed-dose combination products of antiretrovirals, use appropriate combination of the recommended single ingredient comparator products Medicines to treat HIV/AIDS related conditions Acyclovir Zovirax ( Amitriptyline Elavil (Zeneca), Amitriptyline (Sandoz) Amoxicillin+clavulanic acid Augmentin ( Amphotericin B AmBisome (Astellas), Fungizone (Apothecon) Azithromycin Zithromax (Pfizer) Buprenorphine Subutex (Reckitt Benckiser) Ceftriaxone Rocephin (Roche) Ciprofloxacin Cipro (Bayer) Chlorphenamine Piriton ( Clarithromycin Biaxin, Klaricid, Klacid or Zeclar (Abbott) Clindamycin Cleocin (Pharmacia & Upjohn) Codeine Codeine sulfate (30 mg tablet, Roxane, US) 2 Cyclizine Valoid (Amipharm) Dapsone Dapsone (Jacobus) Dexamethasone Dexametasone (2 mg tablet, Roxane, US) 2, Dexamethasone (4 mg/ml injection, Luitpold, US) 2 2 The recommended comparator products are approved by USFDA; the comparator product should be obtained from the US market. Medicines for HIV/AIDS and Related Diseases 2

3 Diazepam Docusate --** Fluconazole Fluoxetine Flucytosine Folinic acid Gancyclovir Hyoscine Ibuprofen Isoniazide, 100 mg, 300 mg tablet Itraconazole Loperamide Methadone Valium (5 mg tablet, Roche) Diazepam (5 mg/ml injection, Hospira, US) 2 Diflucan (Pfizer) Prozac, Lilly Ancobon (250 mg capsule, 500 mg capsule, Valeant, US) 2 Ancotil (500 mg tablet, 10 mg/ml i.v. solution, Meda Pharma) Refolinon (Pharmacia & Upjohn) Cytovene or Cymevene (Roche) Buscopan (10 mg tablet, Boehringer Ingelheim) Pamine Forte (5 mg tablet, Fougera Pharms, US) 2 Scopoderm TTS (Novartis) Transderm Scop (Novartis, US)2 Motrin IB 200 mg tablet (McNeil) Nurofen (Abbott) Isozid (100 mg tablet, Fatol) Isoniazid (100 mg,300 mg tablet, Sandoz, US)2 Sporanox (Janssen Pharmaceutica) Imodium (Janssen-Cilag) Methadose (10 mg/ml conc. for oral solution, Mallinckrodt, US) 2 Methadone hydrochloride (5mg/5ml and 10mg/5ml, Roxane, US) 2 Morphine sulfate (15 mg + 30 mg tablet, Roxane, US) 2 Morphine MS Contin (10 mg + 30 mg + 60 mg extended release tablets, Purdue/Mundi Pharma) Morphine sulfate (10 mg/5ml solution, Roxane, US) 2 Ondansetron Zofran, Pentamidine Pentacarinat (Aventis Pharma or Rhone-Poulenc Rorer) Prednisolone Prednisolone (5mg tablet, Watson Labs, US) 2 Pyrimethamine Daraprim ( Rifabutin Mycobutin 150 mg capsule (Pharmacia & Upjohn US, or Pfizer, EU) Senna --** Sulfadiazine Sulfadiazine (Sandoz) Sulphamethoxazole+trimethoprim Bactrim (Roche), Septrin (Aspen), Bactrim DS (Mutual Pharm, US) 2 Sulphamethoxazole 800 mg + trimethoprim 160 mg +isoniazid 300 mg + pyridoxine 25 mg tablet Bactrim (800/160 mg tablet, Roche) + Isoniazid (300 mg tablet, Sandoz, US) 2 * Valgancyclovir, 450 mg tablet Valcyte 450 mg tablet, Hoffman-LaRoche/Roche * For pyridoxine only dissolution at ph 1.2, 4.5 and 6.8 should be submitted, showing rapid or very rapid dissolution. ** For docusate and senna, only dissolution data should be submitted at ph 1.2, 4.5 and 6.8. Medicines for HIV/AIDS and Related Diseases 3

4 Obtaining comparator Comparator products should be purchased from a well regulated market with stringent regulatory authority. If the recommended comparator cannot be located for purchase from the market of one of the identified countries, the applicant should consult with WHO regarding the sourcing of an acceptable comparator product. Information requirements Within the submitted dossier, the country of origin of the comparator product should be reported together with lot number and expiry date, as well as results of pharmaceutical analysis to prove pharmaceutical equivalence. Further, in order to prove the origin of the comparator product the applicant must present all of the following documents: 1. Copy of the comparator product labelling: the name of the product, name and address of the manufacturer, batch number, and expiry date should be clearly visible on the labelling. 2. Copy of the invoice from the distributor or company from which the comparator product was purchased: the address of the distributor must be clearly visible on the invoice. 3. Documentation verifying the method of shipment and storage conditions of the comparator product from the time of purchase to the time of study initiation. 4. A signed statement certifying the authenticity of the above documents and that the comparator product was purchased from the specified national market: the certification should be signed by the company executive or equivalent responsible for the application to WHO Prequalification Team. Dose equivalence In case the invited product has a different dose compared to the available acceptable comparator product, it is not always necessary to carry out a bioequivalence study at the same dose level; if the active substance shows linear pharmacokinetics, extrapolation between similar doses may be applied by dose normalization. Fixed-dose combination products The bioequivalence of fixed-dose combination (FDC) product should be established following the same general principles. The submitted FDC product should be compared with the respective innovator FDC product as listed above. In cases where a FDC comparator product is not listed above, individual component products administered in loose combination should be used as a comparator. The principles of dose normalization as mentioned above are applicable. Suitability of a comparator product for BCS-based biowaiver applications Recommendation of an API for BCS-based biowaivers is made purely on the solubility, permeability, safety and related properties of the API (Class 1 or Class 3) see the Biowaiver guidance documents on the WHO Prequalification website. It does not imply that the recommended comparator product(s) will be rapidly dissolving in case of Class 1 APIs (or very rapidly dissolving in case of Class 3 API), which is a requirement for BCS based Medicines for HIV/AIDS and Related Diseases 4

5 biowaiver studies. The applicant must thus ensure that the recommended comparator(s) listed on the WHO Prequalificatoin website is indeed suitable for a BCS based-biowaiver application before product development. Note that rapidly dissolving (or very rapidly dissolving) properties of a product are not required for in vivo bioequivalence studies. Thus, though a listed comparator product may not be suitable for BCS-based biowaiver purposes, it is still suitable for in vivo bioequivalence studies. Medicines for HIV/AIDS and Related Diseases 5

Recommended comparator products: Medicines for HIV/AIDS and related diseases

Recommended comparator products: Medicines for HIV/AIDS and related diseases Comparator products should be purchased from a well regulated market with stringent regulatory authority 1. Invited medicinal