Biosimilar Rheumatology Roundup: July

July was a busy month for biosimilars targeting rheumatology indications; this month saw a product launch, developments in the legal realm, new clinical data, and prospective changes to Medicare reimbursement.

July was a busy month for biosimilars targeting rheumatology indications; this month saw a product launch, developments in the legal realm, new clinical data, and prospective changes to Medicare reimbursement.

Merck Launches Biosimilar Infliximab

Merck has announced the US launch of its biosimilar infliximab, Renflexis, developed under a joint venture with Samsung Bioepis. Merck will introduce the drug at a US list price of $753.39, which it says represents a 35% discount to the price of the reference Remicade. That price point undercuts Pfizer’s infliximab biosimilar, Inflectra, which launched at only a 15% discount.

Meanwhile, Samsung Bioepis, in seeking to develop more biosimilars for the US market, is reportedly undertaking shorter clinical trials in order to expedite product approvals.

Is Interchangeability Drawing Nearer?

Boehringer Ingelheim (BI) has enrolled its first patient in a study to demonstrate interchangeability of its biosimilar adalimumab candidate BI 695501 with the reference, Humira. BI 695501 is under review by both the European Medicines Agency and the FDA. In accordance with FDA’s draft guidance on interchangeability, the study will include 3 switches between the 2 products. BI expects results from the study to be available in the second half of 2019.

An analysis of the use of infliximab biosimilar CT-P13, published in Drug Design, Development and Therapy, shows that the available data strongly confirm the equivalence of reference infliximab and CT-P13 from both a pharmacodynamic and clinical point of view. The data are also promising with respect to switching with Remicade. According to the authors, “The findings suggest interchangeability between [Remicade] and CT-P13 as a feasible and safe strategy to be applied in real-life clinical practice.”

However, an analysis of 53 switching studies available in the medical literature found that immunogenicity data are present in only 51% of studies, and a significant information gap needs to be filled by data derived from appropriately designed switching trials and real-world experience.

Adalimumab Biosimilars Are at the Gates

The prospective adalimumab biosimilar CinnoRA, under development by Iranian manufacturer CinnaGen Co, was found to be comparable to AbbVie’s innovator adalimumab, Humira, in a phase 3 trial.

Another study, published in the Journal of Clinical Pharmacy and Therapeutics, found that Samsung Bioepis’ SB5, yet another proposed adalimumab biosimilar candidate, had pharmacokinetic equivalence to both European-sourced and US-sourced adalimumab.

Meanwhile, AbbVie’s hold on the lucrative adalimumab market may be slipping after the US Patent and Trademark Office’s Patent Trial and Appeal Board ruled to invalidate an AbbVie patent on a method of treating rheumatoid arthritis for the second time in as many months.

Biosimilars Gain Uptake, With Some Caveats

A new report from Avalere shows that most US-based health plans cover at least 1 FDA-approved biosimilar, and that 95% of health plans surveyed reported the cost of biosimilars to be a primary factor in the decision to cover biosimilars. However, only 7% of plans have placed biosimilar infliximab in their preferred-brand tiers, while competitive products, including Humira, Orencia, Remicade, and others, have achieved an average of 35% preferred-brand tier placement.

CMS Considers Changing Course on Biosimilars

CMS, in its 2018 Medicare Physician Fee Schedule proposed rule, indicated that it is reconsidering its policy of grouping all biosimilars for a given reference product under a single billing code. The American College of Rheumatology voiced its support for the assignment of unique J-codes to each biosimilar product in order to promote better pharmacovigilance.

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