Biosimilars are biological medicinal products highly similar to another already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
The biosimilars market is complex and highly competitive, offering significant growth opportunities as major originator biologics come off-patent. Differentiation is becoming increasingly important to biosimilar companies with >700 biosimilars in development. It is estimated that by 2020, biologics that represent $55 billion in sales will come off-patent and that the biosimilars market will reach >$20 billion by 2025, even assuming modest market penetration.
- Source: Deloitte 2016 Global Life Sciences Outlook
2. Source: J.P. Morgan, North American Equity Research Nov 13, 2015
What Arecor can do
The Arestat™ technology is uniquely placed to deliver differentiation via innovative formulation within current biosimilar guidance in the form of:
- Market penetration & protection:
- Developing formulations of biosimilar products with Freedom to Operate within an increasingly crowded space and subsequent formulation IP protection
- Improved end-user convenience such as conversion of lyophilised formulations to stable aqueous formulations to remove the need to reconstitute by the end user
- Enhanced stability by removal of cold-chain requirement for some or all of product shelf-life and in-use period
- Life Cycle Management for competitive advantage such as enabling stable aqueous highly concentrated biobetter products to allow more convenient administration (intravenous to subcutaneous switch)