Celltrion has been strategically managing the lifecycle of its biosimilar infliximab as a classic example to look into. After getting its approval to the world’s first subcutaneous version of biosimilar infliximab, Celltrion now strives to develop the world’s first oral infliximab. It has collaborated with Intract Pharma, a U.K. based drug delivery firm to co-develop a tablet version of infliximab. Under the collaboration, Celltrion will supply the drug material to Intract Pharma to develop and advance the oral version to clinical development. Celltrion will take over the clinical development and marketing once phase 2 clinical stage is completed. Medicines and Healthcare products Regulatory Agency (MHRA) has cleared the drug to proceed to phase 1/2b testing without requiring additional preclinical research or clinical safety studies. While infliximab is already approved for 5 indications, the current joint development additionally targets inflammatory bowel disease (IBD) which includes Crohn’s disease and ulcerative colitis.
Celltrion already markets both intravenous and subcutaneous formulations of infliximab, with the oral product it will establish itself as one of the leaders in the TNF-α inhibitor market. The oral product will not only steal a share from parenteral versions of infliximab and other anti-TNF-α biologics but also from oral steroids and immune-suppressants that are currently the standard of care for IBD which often have serious side-effects and do not offer long-lasting respite from the disease as compared to infliximab treatment which has been found to be very effective with a good safety profile. In addition to the product offering ease of at-home administration, the developers also aim for the product to be stable at room temperature which could offer a greater degree of convenience in transportation, distribution and storage.
Oral delivery of biologics has been the aspiration of several biopharma developers but addressing physiological delivery through the gastrointestinal tract has been a tough nut to crack. In 2018, Amgen had teamed with Entera Bio, which specializes in oral delivery of large molecules, to develop oral versions of three biologics but the progress on the partnership was not disclosed publicly. Intract Pharma has also established itself as an oral drug delivery specialist and has established two proprietary platforms Phloral™ and Soteria™ for delivery of large molecules.