3:52 PM
Feb 09, 2018
 |  BC Extra  |  Politics & Policy

American College of Rheumatology recommends biosimilars for rheumatic disease

In a white paper published in Arthritis & Rheumatology, the American College of Rheumatology now recommends the use of biosimilars to treat rheumatic disease, saying they should be incorporated into the U.S. healthcare system.

The authors wrote that they reevaluated their position based on evidence from Europe, as "biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use" and biosimilars gaining traction in the U.S. In 2015, the ACR released a position statement emphasizing that close monitoring of differences between biosimilars and their reference biologics should be examined as new drugs are developed.

Multiple biosimilars of tumor necrosis factor (TNF) inhibitors including Remicade infliximab from Johnson & Johnson (NYSE:JNJ), Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN), and Humira adalimumab from AbbVie Inc. (NYSE:ABBV) are marketed in the EU to treat rheumatic diseases.

In December, FDA approved a third Remicade biosimilar, Ixifi infliximab-qbtx from Pfizer Inc. (NYSE:PFE). Enbrel biosimilars approved in the EU include Benepali etanercept from Samsung Bioepis Co. Ltd., a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung BioLogics Co. Ltd. (KOSDAQ:207940), and Erelzi etanercept-szzs from Novartis AG (NYSE:NVS; SIX:NOVN), while only Erelzi has been approved in the U.S. Four Humira biosimilars are approved in Europe, while two are approved in the U.S.

In the paper, the authors noted that the U.S. approval pathway for biosimilars mandates rigorous comparative studies to demonstrate biosimilarity of the biosimilar candidate to its reference product, including structure and function, pharmacokinetics/pharmacodynamics, stability and formulation, and safety and immunogenicity.

The authors wrote that methods to detect molecular changes due to alterations in manufacturing and assays to detect anti-drug antibodies have improved and become more sensitive. Additionally, pre- and postmarketing studies have shown "reassuring evidence" to support extrapolation and interchangeability of biosimilars.

While the authors believe that the use of biosimilars will improve patient access to biologic agents at a lower cost and encourage a competitive marketplace, an accompanying editorial expressed concern that pharmacy benefit managers (PBMs) would prefer a higher-cost original product, thereby preventing low-cost accessibility to patients.

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