$100 billion of revenues up for grabs for drug manufacturers as patents for key biologics expire

For success in the biosimilars sector, manufacturers must adopt QbD, DoE and PAT initiatives.

Although complexities inherent in biological drug manufacturing are creating barriers for further expansion of the biosimilars market, imminent patent expiries of key biologics are set to create new opportunities for biosimilar manufacturers, according to business intelligence provider GBI Research.

Adam Bradbury and Rishikesh Mandilwar, Analysts at GBI Research and co-authors of the company’s latest report, state that one of the key challenges biosimilar manufacturers face is the knowledge gap under which these products are developed. Indeed, the innovator product information remains proprietary, and manufacturers must adopt a reverse engineering process.

Mandilwar explains: "To be successful in the biosimilars sector, companies must adopt the latest technology and quality initiatives, such as quality by design, design of experiments and process analytical technology. They must also take a proactive approach in risk mitigation by compiling risk-management plans and adopting production best practices outlined by industry associations and regulatory agencies."

A number of biologics are set to go off patent before 2020, which presents a huge opportunity for biosimilar manufacturers. Biologics have managed to leverage relatively high prices, with the average annual price currently $16,425 – more than 20 times the cost of small molecule drugs. However, it is increasingly difficult to maintain high prices. For example, in the UK, NICE has issued recommendations against a series of key drugs based on cost-effectiveness.

Pricing for biosimilars is usually 30–50% lower than the innovator product. These cost advantages will lead to greater access to these drugs, and significantly reduce the cost of healthcare in many countries. By 2020, $100 billion of biologics will be exposed to competition due to patent expiration.

Bradbury concludes: "The biosimilar pipeline is robust, and most products are being developed for the oncology and immunology therapy areas. Over 126 companies are currently involved in biosimilar development, which reflects the significant commercial potential that these products represent."