The latest report by business intelligence provider GBI research shows that new opportunities for biosimilar manufacturers are being presented through patent expiries of key biologics.
Drug Manufacturing
Analysts at the firm report that one of the key challenges biosimilar manufacturers face is the knowledge gap under which these products are developed. In particular, the innovator product information remains proprietary and manufacturers must adopt a reverse engineering process.
Analyst Rishikesh Mandilwar said: ““In order 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.”
The report states that a number of biologics are are set to go off patent before 2020, presenting huge opportunies for biosimilar manufacturers. The average annual price for biologics is currently $16,425, more than 20 times the cost of small molecule drugs. Howeverm relatively high cost is becoming increasingly difficult to maintain. GBI research state that in the UK NICE has issued issued recommendations against a series of key drugs based on cost-effectiveness.
More so biosimilars are priced 30-50% lower than the original product and the cost advantages can lead to greater access for these drugs and reduce the cost of healthcare in many countries. By 2020, $100 billion of biologics will be exposed to competition due to patent expiration.
Analyst Adam Bradbury states: “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.”