|Applicable indicator||Not applicable|
Mylan is one of the largest producers of antibiotics globally by sales volume. As a generic medicine manufacturer, Mylan was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. It has the highest performance among generic medicine manufacturers in scope. The company discloses an environmental risk-management strategy that is applied to its own manufacturing sites. Mylan reports mechanisms for maintaining a high quality of antibiotic production and also requires its third-party suppliers to apply the same quality standards to their production facilities. The company reports no information on where it files products for registration; however, it discloses a general intra-country equitable pricing approach. The company also engages in stakeholder engagement to ensure efficient supply. Regarding stewardship, Mylan adapts its packaging with symbols and pictograms illustrating the necessary antibiotic dosage schedule for patients.
Sales & operations
Mylan, founded in 1961, is a US-based global provider of generic and specialty pharmaceuticals. The company produces and markets innovative and generic medicines, active pharmaceutical ingredients and consumer healthcare products in approximately 165 countries and territories worldwide. The company’s key therapeutic areas include cardiovascular, CNS and anaesthesia, infectious disease, immunology, respiratory and allergy, dermatology and oncology. In 2017, Mylan announced a multilateral agreement to provide a new class of antiretrovirals (ARVs) to low- and middle-income countries. This agreement includes the South African government, the Kenyan government, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative and the Bill & Melinda Gates Foundation (BMGF), among others. Under the agreement, the company will supply a generic fixed dose combination of dolutegravir/lamivudine/tenofovir disoproxil fumarate (developed as part of a licensing agreement with Gilead Sciences Inc. and ViiV Healthcare) for a maximum price of about USD 75 per patient per year. In return, the BMGF will guarantee minimum sales volumes of the drug. Since 2015, Mylan has made several large acquisitions, including those of Meda, Abbott’s non-US developed markets specialty and branded generics business and the non-sterile, topicals-focused specialty and generics business of Renaissance Acquisition Holdings.
Mylan markets at least 49 antimicrobial medicines, 38 of which are listed on the WHO EML (Section 6). Twenty-one of the company’s antimicrobial medicines are antibiotics, with 19 listed on the WHO EML (Section 6), including one on the EML’s Reserve group (linezolid). The remainder (28) of the company’s portfolio comprises two antifungals and 26 antivirals, including 22 indicated for HIV/AIDS, the largest anti-HIV portfolio in the Benchmark.
Expand engagement in antimicrobial stewardship. Mylan adapts its packaging with symbols and pictograms illustrating the necessary dosage schedule for patients. It can expand this practice to more countries in scope* and take further language and literacy needs into consideration. Mylan can engage in more stewardship activities, e.g., through surveillance activities, educational activities for healthcare professionals on AMR (while mitigating conflict of interest), and engage in appropriate promotion practices.
Expand environmental risk-management strategy. Mylan can ensure antibiotic discharge limits are added to its environmental risk-management strategy. It can also extend this strategy to the sites of third parties who manufacture antibiotic APIs on its behalf, as well as to external waste-treatment sites. Mylan has a general environmental risk-management strategy that it applies to its own manufacturing sites.
Ensure affordability and registration plans for new and existing antimicrobials. Mylan disclosed its approach to equitable pricing specifically for its antiretrovirals. It can seek to improve access in low- and middle-income countries through registration of new and existing antimicrobials, and ensure that more products are priced affordably.
Increase engagement in R&D innovation. Mylan is currently engaged in developing new fixed dose combinations of antiretroviral medicines. It can continue to engage in incremental R&D, and ensure access and stewardship provisions are in place for these projects.
A. Research & Development
As a generic medicine manufacturer, Mylan was not eligible for this research area. However, the company is active in antimicrobial R&D.
Two new fixed dose combinations for HIV/AIDS.
Mylan reports that it has two projects in its antimicrobial R&D pipeline targeting a priority pathogen, namely HIV. One project involves a dose reduction to efavirenz (600 mg to 400 mg), in the Fixed Dose Combination (FDC) efavirenz/lamivudine/tenofovir disoproxil fumarate, which has been shown to be non-inferior while containing a reduced drug dose, and can be sold at a lower price. The other project involves dolutegravir/lamivudine/tenofovir disoproxil fumarate, a new FDC for the treatment of HIV/AIDS. In 2017, Mylan received FDA tentative approval for both of these FDCs, as they consist of patented antiretrovirals from Gilead Sciences Inc., Bristol- Myers Squibb Co. and ViiV Healthcare. Mylan commits to pricing these generics affordably. In particular, Mylan has announced a new agreement with UNAIDS and other partners to make the dolutegravir/lamivudine/tenofovir disoproxil fumarate combination available to public sector purchasers in low- and middle-income countries at around USD 75 per person, per year.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Environmental risk-management strategy for own sites.
Mylan has an environmental risk-management strategy that includes minimising the impact of antibiotic manufacturing discharge. The strategy applies to its own sites and includes auditing. At a number of sites in India, Mylan follows a Zero-Liquid Discharge process (ZLD, a water treatment process in which all wastewater is cleaned and reused). The company’s environmental risk-management strategy has not been extended to Mylan’s third-party manufacturers of antibiotic APIs and drug products, or to external waste-treatment plants. The company reports no information about setting discharge limits.
B.2 Limited transparency regarding environmental risk management.
Mylan reports some of its environmental risk-management initiatives in its Global Sustainability Report, published on its website. It does not disclose audit results, or the discharge levels of antibiotics. The company also does not share the identities of its third-party suppliers of antibiotic APIs and drug products, or of external waste-treatment plants.
B.3 Commits to following GMP, including at 3rd-party sites.
Mylan reports that it has mechanisms for maintaining a high quality of pharmaceutical production that includes antibiotic production — namely following GMP standards. This commitment applies to its own manufacturing sites. Mylan requires its third-party suppliers to apply the same quality standards to their production facilities.
C. Appropriate Access & Stewardship
C.1 No information on filing for registration.
Mylan reports no information on where it has filed its newest antibiotics for registration in countries in scope.* This information is not otherwise publicly available.
C.2 Intra-country equitable pricing for antimicrobials.
Mylan discloses a general (not product-specific) intra-country equitable pricing approach. It reports that this applies to at least its 5 highest- volume antimicrobial medicines (all HIV/AIDS medicines) in countries in scope.* Under this general approach, the lowest prices are reserved for Global Fund, PAHO and PEPFAR.
C.3 Taking multiple steps to improve supply chain efficiency.
Mylan engages with the Global Fund, PEPFAR and the South African government to align supply and demand forecasting for five of its highest-volume antimicrobials. These are all HIV/AIDS medicines. The company also has response mechanisms in place for its HIV/AIDS medicines in order to respond efficiently in the event of stock-outs in countries in scope.* These mechanisms are designed to enable Mylan to anticipate and respond to competing suppliers’ stock-outs.
C.4-C.7 Some involvement in AMR stewardship activities.
Mylan adapts its packaging with symbols and pictograms illustrating the necessary dosage schedule for patients. This can help to improve patient adherence to treatment. However, it does not report of any activities in HCP education, appropriate promotion practices, or surveillance programmes.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
† EML Section 6: Anti-Infective Medicines
§ Net sales and other revenues from third-parties; FYE 31 December 2016
|| Third-party net sales; FYE 31 December 2016