- May 2014
- 7 Stan. J.L. Sci. & Pol'y 1
Biosimilars have tremendous potential to reduce the costs of biologic therapies. Emerging markets may represent a significant fraction of future biosimilar production, development, and consumption. Yet safety concerns, price sensitivity, and lower quality standards represent challenges to public health in emerging markets. Well-crafted public-private partnerships between public health agencies, local biosimilar manufacturers, and global pharmaceutical firms that leverage advantages of each can result in biosimilar production targeted to local public health needs using a safety-focused infrastructure. The key clinical risk for biosimilars— immunogenicity—can be addressed by leveraging patient safety tools and incentivizing local producers to work with global drug firms and local public health departments, while technical expertise in large scale current Good Manufacturing Practices (“cGMP”) can be provided by global drug firms. Once this infrastructure is in place, public health departments in partnership with their local and global producers can provide incentives, such as limited market exclusivity, to produce drugs in these emerging markets at higher than required levels (i.e., at or above cGMP). They can also target specific immunotherapies relevant for that particular community’s needs. By doing so, global firms, local producers, and local public health departments can provide direction and improved quality and safety so benefits can inure directly to these populations. Moreover, as global populations begin to rely on these emerging market-produced drugs, greater access, sustainability and affordability may also be promoted.