As some insulin, human growth hormone and other products transition on March 23rd from new drug applications (NDAs) to biologics license applications (BLAs), the recently passed government spending bill included a further tweak to add new proteins to the transition. The NDA to BLA change effectively means that any follow-on products for these NDAs will need to win approval as biosimilars after March. The transition was created by the Biologics Price Competition and Innovation Act of 2009, which clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” to include a “protein”. Learn More