$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.”
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance