FDA approves etanercept biosimilar for psoriasis, psoriatic arthritis

September 21, 2016

The FDA approved the biosimilars Erelzi for plaque psoriasis and Enbrel for psoriatic arthritis.

The FDA approved Erelzi, (etanercept-szzs, Novartis) for several indications, including chronic moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. The injectable biosimilar for Enbrel (etanercept, Amgen) is also approved for active psoriatic arthritis, including use in combination with methotrexate (MTX) in psoriatic arthritis patients who do not respond adequately to MTX alone.

There are almost 10 different biologics approved in the U.S. for psoriatic disease. The first biosimilar approved for psoriasis and psoriatic arthritis was Inflectra (infliximab-dyyb, Pfizer), a biosimilar for Remicade (infliximab, Janssen). Erelzi was the second biosimilar approved for psoriatic disease, according to an article published August 30 on Psoriasis.org.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, says in an FDA press release. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

The FDA approved Erelzi based on structural and functional characterization evidence, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that shows Erelzi is biosimilar to Enbrel. But dermatologists and others should note that Erelzi is approved as a biosimilar; not an interchangeable product. Biosimilars are approved by FDA because they are highly similar to an already FDA-approved biological product and have no clinically meaningful differences from the specific biologic. Interchangeable biological products, on the other hand, not only meet the biosimilarity standard but are also expected to produce the same clinical result as the approved biologic in any given patient, according to FDA.

Next: Benefits for dermatologists

   

Jashin Wu, M.D., who is a member of the National Psoriasis Foundation Medical Board, and director of dermatology research for Kaiser Permanente Los Angeles Medical Center, commented for Dermatology Times on this announcement’s impact on dermatologists and the psoriasis patients they treat.

“As of now, there is minimal impact as the manufacturers of the branded biologics are locked in patent litigation with biosimilar manufacturers. Inflectra was approved by the FDA in April 2016, but it is still not on the U.S. market also due to patent litigation between the biologic and biosimilar companies.  It may be months to years before these patent issues are resolved,” Dr. Wu says.

When the legal dust settles, the main benefits of using Erelzi instead of Enbrel, according to Dr. Wu, will likely be lower copays for patients-perhaps, in the 20 to 30 percent range.

“There may be increased access for patients who otherwise would not be able to obtain a biologic,” Dr. Wu says. “The main concerns would potential loss of efficacy if anti-drug antibodies form due to switching to the biosimilar or new side effects. Non-medical switching due to cost/insurance may result is worse clinical outcomes or increased healthcare utilization.”

For practicing dermatologists, the implications could mean managing more paperwork or approvals.

“If the dermatologist prefers that only the branded biologic be dispensed, some states give the option to not substitute, but then it would on the clinician to select this option,” Dr. Wu says.

Whether the potential cost benefit of biosimilars will trickle down to patients is not a given, according to Dr. Wu.

“… it remains to be seen if the payers will just absorb the cost savings or pass along these savings to patients with lower copays. If a patient cannot afford the copay for a biologic, but can for the biosimilar, then the dermatologist may wish to write for the biosimilar, instead,” he says.