CMS will need to continue to be ‘savvy’ to strategies brand manufacturers already employ to shape the landscape for generic and biosimilar competition, policy expert says.

The US Medicare agency intends to treat all dosage forms of the same active ingredient as a single drug for purposes of its new price negotiation authority. The approach will have implications for product branding and line extension strategies.

Stakeholders differ on whether the rapid growth in spending is to be expected, given the realities in health care and specialty drug costs, or that the data underscores the need for oversight and reform of the 340B program.