The biosimilars market is a complex, highly competitive yet significant growth market. This growth has been driven by clarity in European and US biosimilar guidelines coupled with a large number of major originator biologics coming off patent. This represents a significant market opportunity for biosimilar developers where it is estimated that by 2020 biologics that represent $55 billion in sales will come off-patent (J.P. Morgan, North American Equity Research Nov 13, 2015). It is anticipated that the biosimilars market will reach >$20 billion by 2025, even assuming modest market penetration. There are >700 biosimilars in development (Deloitte 2016 Global Life Sciences Outlook), however, it is clear that only a small number of companies will capture market share for each individual biosimilar product. Therefore, there is a growing market need and opportunity to deliver product differentiation. 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: 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 high concentration monoclonal antibodies to allow more convenient administration (Note: A change in route of administration requires a full review of the development and regulatory implications in relation to the current biosimilar guidance for each intended launch territory).
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Differentiation is becoming increasingly important in the strategies of biosimilar companies with >700 biosimilar products in development, many of these being developed for major territories. Arecor can deliver meaningful commercial differentiation and intellectual property protection via innovative reformulation of its partners’ biosimilar products.