Journalist Dan Stanton reported that Amgen withdrew in September from The Biosimilars Forum, based on disagreements with the remaining eight biosimilar-manufacturing members and perhaps internal conflicts within Amgen.
Founded by 11 members (Allergan, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Epirus Biopharmaceuticals, Merck and Co., Pfizer, Samsung Bioepis, Sandoz, and Teva), 8 now remain (B-I, Coherus, Fresenius Kabi, Merck, Pfizer, Samsung Bioepis, Sandoz, and Teva).
An Amgen spokesperson told Mr. Stanton, “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.”
Areas of disagreement may have arose over the need for policies to support widespread acceptance of biosimilars and innovation in originator biologics, and the types of education and how it is disseminated to support uptake.
Amgen harbors a healthy pipeline of biosimilars as well as defending its brands against biosimilar competition. Whereas its Epogen®, Neupogen®, and Neulasta® are under active assault by biosimilars, its biosimilar versions of adalimumab (Amjevita®) and bevacizumab (Avastin®) are both approved but not marketed in the US.
As was pointed out by Mr. Stanton’s report, Amgen sponsored a YouTube video that supported use of naming conventions that differentate biosimilars from reference products (against the Biosimilar Forum’s advocacy) as well as implying that biosimilar switches can result in negative outcomes. Earlier in November, Forum-member Sandoz issued a statement in support of Pfizer’s Citizen’s Petition, complaining of inaccurate and misleading statements made by makers of reference biologics.
Amgen (as well as Pfizer and Boehringer Ingelheim) must walk a tightrope that other biosimilar-focused manufacturers do not. To be leading innovative drug makers, they systemize their efforts to research new medicines and acquire drug discovery firms, engage in lifecycle management, and aggressively protect their intellectual property. Yet both drug makers seem committed to the biosimilar side of their pipeline and growing the value of their biosimilar enterprises.
The Biosimilars Forum, formed in 2015, is an advocacy organization, competing in the policy space with the Biosimilar Council, which has members that represent a more diverse group (Apobiologix, AmerisourceBergen, Amneal Biosciences, Axinn, Biocon, Biorasi, Boehringer Ingelheim, Dr. Reddy’s Laboratories, Lupin, Momenta Pharmaceuticals, Mylan, and Sandoz). The Biosimilars Council is a division of the Association for Accessible Medicines.