Amgen withdrew its membership from advocacy group The Biosimilars Forum in September after disagreeing on how best to support the US biosimilar market.
Nonprofit organization The Biosimilars Forum was setup in 2015 “to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care… [by providing] evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars,” according to its mission statement.
The founding 11 members were all, unsurprisingly, biosimilar developers. Since 2015, M&A activity and a shakeup of players – Pfizer buying Hospira, Merck KGaA divesting its portfolio, for example – had whittled membership down to nine, but now Amgen has fallen out with the other eight and left the advocacy group.
“We can confirm that in September, Amgen withdrew its membership from The Biosimilars Forum,” an Amgen spokesperson told BioProcess Insider.
“As one of its founding members, Amgen supports the Forum’s mission to advance biosimilars and improve access to biological medicines. Although aligned on this mission, Amgen and the Forum disagree on how best to support the establishment and growth of a vibrant US biosimilars market.”
Aiming for a robust and sustainable market
According to Scott Foraker, vice president and general manager of Amgen’s Biosimilars Business Unit, industry must “advance policies that create a level-playing field, foster biosimilar competition and instill physician and patient confidence” in order to achieve the promised savings in the US health care system.
He added that to grow a robust and sustainable biosimilars marketplace over the long-term, the following is needed:
- Regulators must maintain scientifically appropriate development standards for biosimilarity and interchangeability that will instill physician and patient confidence
- Robust competition on a level-playing field must be established to achieve lower costs in a manner that builds stability over the long-term
- Policies must support both innovation in biological products and widespread acceptance of biosimilars
- Science-based education for stakeholders is needed to promote uptake and proper use
The Biosimilars Forum, along with several of its members, declined to comment on these points or Amgen’s departure when contacted by BioProcess Insider.
Conflicts of interest
Amgen is one of the largest players in the biosimilar space, having 10 biosimilar medicines in its portfolio. This includes Amjevita, a version of AbbVie’s Humira (adalimumab), and Mvasi, a version of Roche’s Avastin (bevacizumab), both of which have been approved in the US.
The firm is, however, one of the most conflicted biosimilars developer with many of its own novel biologic products already being challenged by competitor versions. Biosimilars of Amgen’s Epogen (epoetin alfa), Neupogen (filgrastim), Neulasta (pegfilgrastim) and Enbrel (etanercept) marketed by fellow members of the Biosimilars Forum have all been approved in Western markets.
In August this year in a Citizen Petition sent to the US Food and Drug Administration (FDA), Pfizer accused several reference drugmakers of issuing misleading communications about biosimilars. While pureplay novel biologics firms J&J and Roche were cited, Pfizer also took a swing at Amgen for publishing a YouTube video about the naming conventions and identifiers for biosimilars.
The video says switching biologics “carries risks, given that no two biologic medicines are identical, and thus can behave differently in the body. Switching drugs is not a good idea if your medicine is working for you,” something Pfizer said implies that switching generally is risky, and undermines the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and FDA’s efforts to promote the use of biosimilars.
At the time, Amgen replied to Pfizer’s accusations in comments sent to this publication, attacking Pfizer’s comments to the FDA regarding draft guidance on nonproprietary naming of biosimilars. Amgen has told us it fully supports distinguishable nonproprietary names to facilitate pharmacovigilance and inadvertent substitution.
Earlier this month, BioProcess Insider reported on the prospect of Big Pharma exiting from the biosimilars space over the next decade. Despite its departure from The Biosimilars Forum, Amgen has expressed its commitment to its biosimilar program in comments made to this publication and elsewhere.
This article has been updated on November 27 to make it clear that Amgen fully supports distinguishable nonproprietary names for biological products.