October 7, 2016
While FDA recently approved two new biosimilars for rheumatoid arthritis and other inflammatory diseases, questions remain about how quickly physicians and patients will embrace the new drugs.
In late September, FDA approved Amgen’s adalimumab-atto (Amjevita), a biosimilar to Humira, to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and other inflammatory conditions. Earlier that month, FDA gave the green light to Sandoz’s etanercept-szzs (Erelzi), a biosimilar to Amgen’s top-selling Enbrel, for rheumatoid arthritis and other inflammatory conditions.
Plus, filgrastim-sndz (Zarxio) from Novartis/ Sandoz has been on the market since earlier this year.
“This [Amjevita] is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research, in a press statement.
There is no doubt that biosimilars for RA stand to save the U.S. healthcare system millions of dollars. AbbVie’s revenue from Humira was more than $14 billion in 2015, making it the top-selling drug in the U.S., according to 24/7 Wall St. Enbrel, meanwhile, netted sales of $5.1 million in the U.S. last year, according to Fortune.
In addition, total savings to the U.S. healthcare system from all biosimilars are projected to reach between $57 and $110 billion from 2015 through 2020, according to the IMS Institute for Healthcare Informatics.
“The RA category is one of the most costly for payers. For this reason, to the extent and pace of their uptake, biosimilars will save U.S. society, individual payers, and patients quite a lot of money. How much money, how soon, and with what market share will depend on several factors,” said Elan Rubenstein, PharmD, Principal of EB Rubinstein Associates, a managed care and pharmaceuticals consultancy.
However, Rubenstein is concerned that “physicians, patients and payers will be reluctant to move patients stabilized on originator biologics to biosimilars, despite the potential for savings.”
The uptake of biosimilars for RA partially depends on whether the FDA will designate any of the biosimilars as “interchangeable”, which will make the drugs far more attractive to payers, prescribers, and patients, according to Rubenstein.
And, while physicians will prescribe biosimilars for RA, “Don’t expect physicians to switch patients from originator products on which they are stabilized to biosimilars, due to the concern that this may destabilize patients. It will take more experience with biosimilars before prescribers and patients are comfortable with that,” Rubenstein said.
There is also uncertainty about how insurers plan to handle biosimilars for RA. “What extent will payers be concerned with the product quality, depth of experience, and ability to provide sufficient quantity without stock-outs of small manufacturers, or manufacturers established in recently specifically to commercialize biosimilars, relative to well-known named manufacturers? How much lower must the net price of a small or new manufacturer’s biosimilar be to overcome payer concerns with small or new manufacturer quality, experience and ability to supply product?...If a payer takes a leap of faith to contract with the cheaper biosimilar made by a small or new manufacturer, what might be the consequences should things not go as planned?,” Rubenstein asked. “Payers will surely consider these worst case scenarios: What will they conclude regarding the balance of lower cost versus potential risk?”