Inflectra vs. Remicade study could be just what the doctor ordered for biosimilars

A study released today that pitted Hospira's biosimilar Inflectra against its reference drug Remicade in patients with rheumatoid arthritis is good news for Hospira ($HSP), and by default Pfizer ($PFE). It found that patients who were switched to the copy did just as well, with no unexpected side effects, as they had on Merck ($MRK) and Johnson & Johnson's ($JNJ) Remicade.

The news is good for Pfizer because it is in the process of buying Hospira in a $17 billion deal. But it is potentially good news for other makers of biosimilars. While the copies have yet to hit the U.S. market, some have been around in Europe for years. But uptake has been slow. According to Reuters, they were generally prescribed to new patients because doctors were reluctant to move patients to them, concerned their patients might do as well on the cheaper versions. That has been a disappointment to government payers in Europe who hope to save billions of euros from biosimilars.

In fact, Finland had hoped to dispel that concern when it funded the head-to-head study after Hospira's Inflectra was approved in 2013. The study compared outcomes in 39 patients who were on Remicade for about 11 months after having used Remicade for about four years to treat "severe diseases such as rheumatoid arthritis (RA) and ankylosing spondylitis (AS)," Hospira said today in an announcement. The study found that, "Patient symptoms and disease activity were similar before and after the switch" and there weren't any "safety signals" observed.

Dr. Tuulikki Sokka

"Real world studies such as this can help provide additional confidence in biosimilars, giving clinicians an opportunity to reduce healthcare spending and provide greater access to biologic medicines for patients in need," Dr. Tuulikki Sokka, head of rheumatology at Jyväskylä Central Hospital in Finland and author of the study, said in a statement.

In Norway, however, wholesalers accomplished what payers had hoped for by engaging in a biosimilar price war there. Finnish drug company Orion Oyj, which licenses the Remicade biosimilar made by Hospira's partner Celltrion, started deeply discounting it after losing public contracts to Hospira. The company started last year with a 39% discount and picked up about 6% to 7% of the market. By February 2015, the discount reached 69% and the biosimilar moved on to grab 50% of the market. Health officials said the cheap prices convinced doctors to try the drug. With that kind of pricing the company won the Norway tender back from Hospira, which was offering a 51% discount for Infectra.

There are big hopes that biosimilars will dramatically cut drug spending in the U.S. The FDA recently approved the first biosimilar for the U.S., a copy of Amgen' ($AMGN) white-blood-cell-boosting blockbuster Neupogen. The biosimilar was developed by Novartis ($NVS) but its launch had been held up by patent litigation filed by Amgen. Celltrion, which is seeking FDA approval for its Remicade copy, hopes to launch that drug in the U.S. yet this year.

- here's the release
- read the Reuters story

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