This week the U.S. Supreme Court made the unanimous decision that manufacturers of low-cost biosimilar drugs are not required to wait 6 months after FDA approval to launch products, reversing a previous 2015 ruling.
Biosimilars are a rising category of the U.S. drug market. Because they are made from living cells, they cannot be adapted to make generic versions of drugs. Biosimilar drugs have been very effective in disease treatment, but can also be expensive. The Supreme Court’s recent decision is expected to save consumers and the U.S. Health System billions of dollars. Manufacturers of biosimilar drugs will also be able to bring products to market much faster.
If you have any questions, please feel free to contact Focal Point Research Inc. We are industry leading Canadian and U.S. Drug Regulatory Consultants that you can trust to help guide your company in the right direction.