As biosimilars gradually gain steam in the U.S. market, one of the biggest manufacturers of the copycat biologics has unveiled a plan to boost uptake across the globe.
In its new Act4Biosimilars action plan, Novartis' Sandoz has laid out a plan to triple biosimilar uptake over the next decade.
The action plan details key challenges preventing access to biosims and the “actionable steps” needed to overcome the obstacles. The company's first report focuses on the Americas.
The Americas analysis shows that in the U.S., regulatory guidelines on interchangeability need to be revised in order to prevent confusion and misconceptions. Similar confusion is taking place in Columbia and Ecuador, as biocopies (which are not comparable biologics) create patient safety risks, Sandoz says.
Sandoz states that biosimilar adoption must be accompanied by education, preferably through a multi-stakeholder approach to combat disinformation. The action plan follows the “4A’s of biosimilars,” which are approvability, accessibility, acceptability and affordability.
The steering committee is working with stakeholders across the Americas to kick off the initiative and address the challenges described in the report. Up next, the efforts will move to the Middle East and Africa in the first quarter of 2024, then Asia Pacific in the second quarter of 2024 and Europe in the fourth quarter of 2024.
Sandoz’ work will be laid out on the impact index, which will be updated every two years.
In the U.S., a rush of biosimilars to AbbVie’s megablockbuster Humira is about to enter the market in full force this July, following Amgen’s January launch of its copycat.
Amgen offers two different price points for its Humira biosimilar Amjevita, one 55% below Humira’s list price and the other with a 5% discount. However, the more expensive version stands to be more popular with payers due to rebate dynamics, calling the cost-savings of the copy into question.
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