Biosimilars Approved by U.S. Supreme Court for Speed to Market

Supporting the rapidly-growing biologics market, the U.S. Supreme Court recently approved the launch of biosimilars for rapid development and commercial launch. Biosimilars are biopharmaceutical drugs which have been designed after their already-licensed counterparts, to have no clinically meaningful difference. Essentially, a biosimilar is a generic version of the same biological drug.

With rising prices becoming a concern, the Supreme Court has cut the time it will take for biosimilars to get to market. The companies that are producing biosimilars no longer have to give the brand-name manufacturer 180 days notice before their launch. This ruling will make it easier and quicker for patients to access the life-enhancing treatments they need. There are still caveats to the biosimilars market – prescriptions cannot be used interchangeably. Patients who wish to take advantage of the new biosimilar would need a new script. But by cutting the time it takes for these versions to hit the market, there will be an increase in biosimilars in the market. This increase will expand competition and hopefully drive down the cost of the biologic therapies that are currently on the market.

Unlike traditional small molecule drugs (most common drugs are small molecules), biologics are produced using active DNA or biological material from living bacteria, such as E.Coli, yeast or others. This pharmaceutical production results in large quantities of active bacteria, and the wastewater must be treated.

PRI Bio designed the AutoFlow Continuous Effluent Sterilization system for just this purpose, supporting continuous biologics production. The AutoFlow can treat anywhere from 500 to 6,000 Liters per hour, in a fully automatic operation, while maintaining a small footprint.