FDA Commissioner, Dr Scott Gottlieb, made a statement on the release of the BAP, which was published on the agency’s website. “We know that biologics are used to treat many serious and life-threatening diseases. They’ve become a mainstay in the treatment of cancer and autoimmune conditions… So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation,” he said. “Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products.”

Rahael Maladwala, pharma analyst at GlobalData, offered his view on what this means for the price of branded biologic molecules:

“We believe that this is another positive step in the chase for value-based pricing. The US has long had a problem with the cost of drugs, with the high annual cost of therapy (ACOT), proving to be a burden for healthcare providers and payers; and as such, a move to ‘value based’ pricing, where cost effectiveness is taken into account as well as safety and efficacy, has been in the making for a while. The BAP is another FDA initiative that looks to increase competition for biologics and in turn, reduce prices.

Follow the links below for the official FDA Statement and recent Approvals.



Specialty drugs

Source: https://www.epmmagazine.com/news/fda-action-plan-on-biosimilars-is-another-positive-move/