Mylan

Leading Practices

• Mylan is the one of the largest suppliers of generic HIV drugs, with over 30 products on the WHO prequalification list.
• Mylan has a needs-based marketing approval approach for HIV/AIDS drugs and has committed to wide and fast registration of its HIV medications and to reliable and sustainable delivery of products that meet international quality standards.
• The company has successfully developed adaptive formulations of HIV drugs including both pediatric formulations and FDCs. The company has made commitments to further investments in this area. Most of these products will be distributed through UNITAID and the Clinton HIV/AIDS Initiative.
• The company has used the FDA tentative approval process for its new adaptive HIV/AIDS products.

Changes Compared to Index 2008

• Mylan was not included in Index 2008.
• During the period of analysis the company has received new marketing approvals for HIV/AIDS adaptive products and has worked closely with international organizations for their distributions.

Suggested Areas for Improvement

• Mylan has a low disclosure of its pricing strategies for new HIV products and also on ATM-related public policy positions, lobbying activities and marketing practices in the Index Countries.
• The company's ATM strategy only covers its ARVs, not to all its Index Disease products.
• Mylan does not have an annual reporting on ATM-related policies, targets and practices.