Putting the boot into biologic strategies

Is it time for healthcare regulators and patent offices to limit the strategies used by existing biologic manufacturers and allow new suppliers to reach some of the world’s most lucrative healthcare systems? Elizabeth Ward of Virtuoso Legal investigates.

British comedian Ricky Gervais once famously quipped that “where there is a will, there’s a relative”. The same applies to all lucrative opportunities—if there’s room for debate or litigation then people will fall out over who gets the money, especially if the money involved is substantial.

Generics and biosimilars are high-value properties and provide some spectacular opportunities for full-on fights in the pharma industry. With some blockbuster biological compounds coming off patent over the next few years, the arguments over when and how biosimilar competitors are granted product approvals and at what cost are starting to emerge.

The healthcare industry is facing a real problem in maintaining its profitability and financing its ongoing commitment to invest in future research. Despite increased efficiency in drug approvals and research costs, the cost of getting drugs to market is as high as ever and regulators are often struggling to keep pace with the science and the opportunities presented by new products. In addition, governments and insurers across the world are looking to control costs and open up competition for the benefit of the consumers globally.