Biotech Movers and Shakers: Eye on Oncobiologics

Jackie Syrop

We'll feature the latest biotechnolology "movers and shakers"--and how they are impacting the biosimilars industry.

Biopharmaceutical company Oncobiologics is up against the world’s largest biotech and pharma companies in its mission to produce biosimilars that will be marketed at significantly lower prices than the original drugs, and which will be designated as interchangeable as well.

That’s the message Oncobiologics Chairman, President, and CEO Pankaj Mohan sent in a recent interview conducted at the JP Morgan Healthcare Conference 2017 in San Francisco, reported by MedCity News. “We don’t believe that giving a 20% to 30% discount is going to move the needle in terms of healthcare savings,” he said. To make a real impact on the cost of drugs, the reduction should be much deeper: around 50%.

Oncobiologics is a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing, and commercializing complex monoclonal antibody biosimilar therapeutics. Its Humira (adalimumab) biosimilar, ONS-33010, received its first approvals for global Phase III clinical trials in June 2016.

Mohan has previously been quoted as saying biosimilars should cut up to 50% off reference product prices because taking 15% to 20% off the price of the original drug is not a significant enough saving for payers, who are looking for saving 40% to 50%--especially for a product like Humira.

Mohan believes that a key element to the company’s success marketing its biosimilars will be not just FDA marketing approval but a designation of interchangeability—which has not been granted to any of the four currently FDA-approved biosimilars. He said the FDA (and the European Medicines Agency [EMA]) are willing to work with biosimilar sponsors on a more effective approval process, and that although the FDA’s guidance on interchangeability is not yet available, Oncobiologics has been able to work with and learn from the FDA to create a program that the agency could eventually approve. Oncobiologics received approval to combine studies on both biosimilarity and interchangeability for ONS-33010 into a single Phase III trial.

Mohan noted that Oncobiologics eliminates inefficiency and waste by combining its operations into a single, integrated facility in Cranbury, New Jersey, rather than establishing manufacturing and product development in two different countries. He attributes these practices to a faster production cycle, another factor that he expects to be critical to the company’s success and ability to market biosimilars. Finally, acknowledging the tremendous resources available to the companies marketing reference medications that allow tremendous investment in continuing legal fights to extend market exclusivity, Mohan calls for greater progress to be made in preventing “evergreening” of drug patents beyond their initial window of exclusivity.

He believes this trend began in 2016, with movements against the high cost of drugs and health care: “I would say it's an irreversible socio-political movement.”