Amgen Withdraws Its Membership from the Biosimilars Forum

A founding member of the Biosimilars Forum has withdrawn its membership from the organization. Amgen has confirmed to The Center for Biosimilars^® that it gave up its membership in the group in September of this year.

In a statement provided to The Center for Biosimilars^®, Amgen said that it supports the Forum’s mission to advance biosimilars and improve access to biologic therapies, but that the parties disagreed on how best to support the development of a vibrant US market for biosimilars. Amgen emphasized that its priorities include promoting scientifically appropriate development standards for biosimilarity and interchangeability, development of a level playing field to achieve lower costs and long-term stability in the marketplace, enactment of policies that support innovation and acceptance of biosimilars, and the promotion of science-based education for stakeholders.

“As a manufacturer of both originator biologics and biosimilar medicines, Amgen is fully committed to the success of the biosimilars market and to our biosimilars portfolio of 10 biosimilars—2 approved in the United States and 3 approved in the European Union—which target important biological medicines,” said Scott Foraker, vice president and general manager of Amgen’s biosimilars business unit. “To achieve the promised savings in the US healthcare system from biosimilars, we need to advance policies that create a level-playing field, foster biosimilar competition and instill physician and patient confidence.”

While Amgen did not specify where its objectives diverged from those of the Biosimilars Forum, the withdrawal follows the August 2018 filing of a citizen petition by a fellow Forum member, Pfizer, on communications about biosimilars.

In the petition, Pfizer cited multiple communications from reference biologic product sponsors that it characterized as misleading, including an April 13, 2018, tweet from Amgen that suggested that patients could react differently to biosimilars than to reference products. The petition also highlighted an Amgen-sponsored YouTube video that implied that switching to a biosimilar was undesirable for a patient who is well controlled on a reference product.

“Misleading statements like these, and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read the petition.

This month, Novartis, parent company of Sandoz, another Forum member, expressed its support for Pfizer’s petition, highlighting the need for additional FDA action and oversight “to help ensure a truthful environment exists within which healthcare providers and patients can make treatment decisions without harmful misinformation about biosimilars.”

The Biosimilars Forum declined to comment on Amgen’s withdrawal.