Biosimilars in Rheumatoid Arthritis: Wave of the Future?

Alice Goodman

June 13, 2014

PARIS — HD203, a biosimilar of etanercept, is equivalent to the original compound, as is BOW015, a biosimilar of infliximab. These findings come from 2 separate phase 3 randomized double-blind trials.

Both studies were presented here at the European League Against Rheumatism Congress 2014.

"As more biosimilars become available, it is critical that patients, healthcare providers, and regulators have confidence in the safety and efficacy of these compounds," said Sang-Cheol Bae, MD, from the Hanyang University Hospital for Rheumatic Diseases in Seoul, South Korea.

Dr. Bae reported results from the comparison of HD203 and etanercept.

"Our study met the primary end point of demonstrating equivalence of HD203 and etanercept," he said. In addition, the safety profile of HD203 was comparable to that of its reference biologic.

HD203 vs Etanercept

The etanercept study involved 294 Korean patients with active rheumatoid arthritis, all of whom received subcutaneous methotrexate twice a week for 48 weeks. In addition, half the cohort received HD203 25 mg and half received etanercept 25 mg.

The proportion of patients who achieved the primary end point — American College of Rheumatology response of at least 20% (ACR20) at week 24 — was not significantly different between the HD203 and etanercept groups (82.48% vs 81.36%; P = .6706).

The proportion achieving ARC20 at week 12 and week 48 was also not significantly different between groups.

However, the proportion of patients who achieved a response of at least 50% (ACR50) was higher with HD203 than with etanercept at week 24 and week 48.

There was no significant difference in treatment-emergent adverse events between the HD203 and etanercept groups (76.87% vs 78.08%). No unexpected adverse events were reported, and few patients in the 2 groups were antidrug antibody-positive.

BOW015 vs Infliximab

The comparison of BOW015 and infliximab was presented by Jonathan Kay, MD, from the UMass Memorial Medical Center in Worcester, Massachusetts.

The study involved 189 patients with active rheumatoid arthritis, all of whom were receiving stable doses of methotrexate. The primary end point was the proportion of patients who achieved ACR20 at week 16.

Responses were evaluated at weeks 0, 2, 6, and 14, in addition to the 16-week end point, making this study different from other studies of biosimilars, Dr. Kay explained.

The proportion of responders at each of the time points was comparable in the 2 treatment group. "This provides particularly convincing evidence that these compounds are therapeutically equivalent," he said.

Biosimilars are currently approved in Asia, Canada, Europe, and India, but not in the United States. Many companies are developing biosimilars. In Korea alone, 6 or 7 companies are in the process of bringing biosimilars to market, according to Dr. Bae.

Great Expectations

"There are high expectations for biosimilars," said Maya Buch, MD, from the Leeds Institute of Rheumatology and Musculoskeletal Diseases in the United Kingdom.

"How they are perceived by rheumatologists and the healthcare system depends on what the studies show. The jury is still out on how big an impact biosimilars will have. Rheumatologists need to have confidence that they are truly equivalent," Dr. Buch told Medscape Medical News.

However, "we have to be mindful of potential bias when looking at studies," she cautioned.

Although it is expected that biosimilars will be much less expensive than biologics, they still need to be proven cost-effective. "It will be interesting to see where they will be costed out," Dr. Buch said.

The study by Dr. Bae's team was supported by Hanwha Chemical. Dr. Bae has disclosed no relevant financial relationships. Some of his coauthors are employees of or have financial relationships with Hanwha Chemical. Dr. Kay reports financial relationships with AbbVie, Eli Lilly, Roche, Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Epirus Biopharmaceuticals, Genentech, Hospira, Janssen Biotech, and Pfizer. Some of his coauthors report financial relationships with a variety of companies. Dr. Buch reports financial relationships with AbbVie, Bristol-Myers Squibb, Roche-Chugai, and Pfizer.

European League Against Rheumatism (EULAR) Congress 2014: Abstracts OP0011 and OP0012. Presented June 10, 2014.

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