The Attraction of Biosimilar Companies
April 08, 2013
The Pharmaceutical market is undergoing a period of significant change where we have seen a global drop in R&D spend. The reverse is true of the market for Biosimilars or Subsequent Entry Biologics as it is known in Canada.
Potential opportunities with Biosimilars have led to a significant number of generics companies entering the market with varying levels of success. We see Pharmaceutical companies partnering with Biotech, as well as contract manufacturing organisations with Biologics capability joining the game.
Biosimilar manufacturing is a fascinating area as, while it offers the opportunity for product improvement, it also throws up new challenges with the need to recreate complex live molecules. During process development, the final product and its quality specifications are known to the research team but it’s a question of successfully arriving at the same result created by the product originators. QbD (Quality by Design) tends to be a key element of the development process as the reference product needs to be closely matched. This means that the Biosimilar organisation is required to follow a significantly tighter development process than the originator.
The exciting aspect of Biosimilar development is the opportunity to improve the manufacturing process. Due to constant developments in manufacturing technology, opportunities may arise to use more advanced platforms and expression systems that are able to produce improved titres and purity levels – and in so doing to increase potential revenue. Investing in equipment and setting aside manufacturing capacity can be a challenge in itself and one that is felt more acutely by Biotech companies. This has led to contract manufacturers entering the Biosimilars market as a result of their inherent flexibility around manufacturing capacity and their tendency to lean towards innovative and cost effective manufacturing technology. In general, contract manufacturing organisations are taking two approaches to Biosimilar manufacture. They either rigidly adhere to the originator methodology with respect to cell lines and yields – or they apply every advancement in cell line and process technology in order to gain a more robust and efficient process.
If the CMO or Biologics company opts to ‘improve’ rather than ‘copy’ the manufacturing process, this will often allow them to improve yields, lowering costs by reducing the scale of manufacturing. If new technologies are applied to upstream processing, this can also reap significant improvements. This can occur in situations where the originator’s process is dated and an advanced upstream process can be applied, resulting in a significant improvement in yield. In some cases, this can lead to downsizing in commercial manufacturing from 10,000L to as little as 500L.
Clearly those who understand the nuances of this area are valuable assets to Biosimilar companies. Talentmark has considerable experience of building such teams for clients and we continue to note a high level of interest in career moves to Biosimilar companies from those within originator organisations. This has led to an increase in the number of people making this move in the last year. By maintaining an up to date scientific, as well as commercial, knowledge of this area, Talentmark is well placed to help clients grow teams that build profits whilst steering their company safely through the scientific and quality standards that these roles demand.