Biosimilars for psoriasis coming appear safe, effective

In the United States, infliximab-dyyb (Inflectra, Celltrion) has largely replaced infliximab (Remicade, Janssen). However, dermatologists rarely use infliximab infusions nowadays, according to Mark Lebwohl, M.D., and M. Alan Menter, M.D., Dr. Lebwohl is the Waldman Professor and Chairman, Kimberly and Eric J. Waldman department of dermatology, Icahn School of Medicine at Mount Sinai, New York. Dr. Menter is professor and program director of dermatology at Baylor Scott & White Health, Dallas. 

The only biosimilar Boni Elewski, M.D., prescribes is infliximab, which her institution generally uses for hospitalized patients with erythrodermic psoriasis. She is chair, department of dermatology and James Elder Professor of Graduate Medical Education at the University of Alabama at Birmingham (UAB).

Some insurers insist that patients fail adalimumab before trying an IL-17 or IL-23 drug, she adds.

“I foresee these companies insisting on adalimumab biosimilars when they become available, if they are less costly,” she says.

Although the U.S. patents for etanercept (Enbrel, Amgen) and adalimumab (Humira, AbbVie) have expired, says Dr. Menter, their biosimilar equivalents have been in legal limbo over multiple lawsuits regarding patents and antitrust issues.

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Two etanercept biosimilars - etanercept-szzs (Erelzi, Sandoz) and etanercept-ykro (Eticovo, Samsung Bioepis) - have earned FDA approval but have yet to reach the U.S. market.

In May, Boehringer-Ingelheim became the last of several challengers to AbbVie’s adalimumab patents to settle its litigation and forestall introducing its drug adalimumab-adbm (Cyltezo) until 2023.8 Other adalimumab biosimilars that will debut that year include the following:
• adalimumab-atto (Amjevita, Amgen)
• adalimumab (Imraldi /SB5, Merck/Samsung), which still awaits FDA approval
• adalimumab (Hulio, Mylan)
• adalimumab-adaz (Hyrimoz, Sandoz)

Several biosimilars for adalimumab and etanercept are available in Europe and the United Kingdom.

For a complete list of biologics and biosimilars in development stateside, please see Table 1.
For FDA-approved biologics for psoriasis and PsA, see Table 2.

Specialty notwithstanding, Dr. Menter says originator biologics can cost $35,000-$50,000 annually.

“The biosimilars are likely to be up to 25% cheaper,” he adds.

However, says Dr. Lebwohl, makers of biologic reference drugs can provide discounts or rebates that approximate the biosimilar price. And pharmacy benefit managers prefer the high sticker price and deep discount, he says, because under Obamacare, they can subtract the full list price from their premiums.

Obamacare rules require insurers to spend at least 80% of their premium dollars on drugs, doctors and hospitals.

“If a drug costs $80,000,” Dr. Lebwohl says, “the insurers can subtract that from the total of their premiums. But if another drug costs $40,000, they can only subtract $40,000. So, they would rather get an $80,000 drug with a $40,000 rebate or discount because they still get to subtract the $80,000 from their premiums, but $40,000 goes right in their pocket. And that’s been a hurdle to the biosimilars.”

Based on current data, Drs. Menter and Lebwohl say biosimilars are therapeutically equivalent to their progenitors. Dr. Menter says that the best trial in this regard is the 27-center NOR-SWITCH trial. It showed no difference in efficacy or safety in patients switched from infliximab to Inflectra after one year.1

“In clinical practice,” Dr. Menter adds, “there have been no new issues related to the biosimilars that we need to be concerned about.”

As TNF-alpha blockers, the biosimilars coming out in the United States must carry a black-box warning about infection and malignancy. However, IL-17 and IL-23 inhibitors carry no such warnings.

“They appear to be safer,” Dr. Lebwohl says. “So the biosimilars are coming out just at the time when we would rather be using drugs coming out that are safer and more effective.”

Disclosures:

Dr. Lebwohl is a paid consultant to Boehringer-Ingelheim. He is also an unpaid investigator for most other companies making biologics for psoriasis (Mount Sinai receives payment from these companies).
Dr. Elewski has been a clinical researcher (with funds going to UAB) for AbbVie, AnaptysBio, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Incyte, LEO Pharma, Merck, Menlo, Novartis, Pfizer, Regeneron, Sun Pharmaceuticals, Valeant (Ortho Dermatologics) and Vanda. She has also been a consultant (honoraria) for Boehringer-Ingelheim, Celgene, Eli Lilly, LEO Pharma, Menlo, Novartis, Pfizer, Sun Pharmaceuticals, Valeant (Ortho Dermatologics) and Verrica.
Dr. Menter has been a paid investigator and consultant for all companies making biologics for psoriasis, but he owns no stock in any of these companies.

References:

1. Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304-2316.