John Murphy III, CEO of the Association of Accessible Medicines (AAM), opened the conference by welcoming the participants and providing an interesting walk through the current environment and how the AAM hopes to navigate the current political environment to make drug products, both generic and biosimilars, more accessible and affordable.
He noted that “affordable medicines did not happen by accident, but by competition,” further noting that the success of competition depends on scale and that, in 2024, generics and biosimilars accounted for saving of over $460 billion dollars. Issues that impact these savings include patent thickets, procedural actions by innovators, reimbursement and access (PBM issues), along with payment programs not universally adopting generics first in drug dispensing decisions by insurers or government payors adversely impacting drug expenditure savings.
He also noted that, while biosimilars have made real progress in terms of the FDA streamlining their review and approval, the uptake of biosimilars has not been as great as anticipated. Continued programs that raise public awareness of biosimilars, and some of the trends that the FDA is using to streamline the biosimilar review and approval process, need to be enshrined in legislation to protect the FDA’s stated positions.
According to Murphy, supply chain security and resiliency are important, but not everything can or has to be made in the U.S.; however, security to bring a certain level of manufacturing back to the U.S. is an attainable goal. Generic drugs and biosimilars are strategic assets for the United States and there needs to be a favorable balance that can protect U.S. drug supplies.
We will have more to you on the goings on at Access 2026 tomorrow.
