FDA’s Woodcock: Give biosimilars a chance

November 5, 2016|Psoriatic Arthritis ICYMI

EXPERT ANALYSIS FROM A BIOSIMILARS IN RHEUMATOLOGY SYMPOSIUM

Zarxio (filgrastim-sndz).
Inflectra (infliximab-dyyb).
Erelzi (etanercept-szzs).
Amjevita (adalimumab-atto).

Physician perspective

“Everything I have heard suggests that biosimilars will be useful, but the scientist in me is a skeptic,” commented Donald Massenburg, MD, PhD, a rheumatologist at Wheaton Franciscan Healthcare in Franklin, Wisc., in an interview.

“I feel better now after learning that current biosimilars are not considered interchangeable, meaning that there can’t be substitutions made without the treating physician’s consent,” he said.

He acknowledged that “I wouldn’t be that excited” if a specific biosimilar was approved for interchangeability and was given to his patients without his knowledge.

Dr. Massenburg pointed to data from the NOR-SWITCH trial comparing the biosimilar Remsima to the reference product Remicade for treatment of rheumatic diseases, psoriasis, and inflammatory bowel disease. The trial showed that Remsima was noninferior to the reference product.

But as noted at the symposium by Paul W. Tebbey, PhD, of the Medical Affairs Division of AbbVie, maker of the innovator biologic Humira, 26.2% of all patients on Remicade in the NOR-SWITCH trial had disease worsening on study, compared with 29.6% of those the biosimilar Remsima. Disease worsening among patients with psoriatic arthritis was seen in 53.8% of those on the reference drug vs. 61.5% of those on the biosimilar.

“I would like to be able to say whether a patient should be switched to a biosimilar or not just because of that potential risk,” Dr. Massenburg said.

A rheumatologist in private practice in New England said that what’s really needed in rheumatology is not the availability of more drugs that act like other drugs, but innovative research into therapies with better targeted mechanism of action.

“We’ve been through the ‘me-too’ hype; we did that with nonsteroidal anti-inflammatory drugs,” said J. Scott Toder, MD, director of the Toder Rheumatology and Osteoporosis Center, Providence, R.I.

“I think we need to concentrate on innovative therapies, and we may be able to do something about the escalating price of the biologics on the market by creating drugs with new mechanism of action to actually increase competition and hopefully control prices. I don’t think that having multiple drugs with the same mechanism of action is in the best interest of our patients,” he said in an interview.

Dr. Woodcock, Dr. Massenburg, and Dr. Toder reported having no relevant disclosures.