Johnson & Johnson Falls as FDA Staffers Back Celltrion's Remicade Biosimilar
February 8, 2016
By Mark Terry, BioSpace.com Breaking News Staff
On Friday, a U.S. Food and Drug Administration (FDA) panel indicated that South Korea-based Celltrion Inc. ’s biosimilar version of Johnson & Johnson Remicade was “highly similar” to the brand name drug. This would seem to clear the way for a Tuesday meeting of the FDA Arthritis Advisory Committee Meeting, which will decide on recommending approval of the drug for rheumatoid arthritis and inflammatory bowel conditions, such as Crohn’s disease.
Biosimilars are drugs that are similar enough to known products to be interchangeable. The Patient Protection and Affordable Care Act (PPACA) amended the Public Health Service Act (PHS Act) to allow a shortcut licensure pathway for biosimilars. The primary rationale for biosimilars is that it will increase competition among drug makers, which will result in a drop in drug prices for consumers.
Joseph P. Fuhr Jr., a professor of economics at Widener University, wrote in an August 2014 Forbes article, “It is estimated that the potential savings in the U.S. from just 11 biosimilars over the time period from 2014 to 2024 could be $250 billion. For the same 10-year period, the savings for California alone would be $27.6 billion from the same 11 biosimilars.”
A legal framework for biosimilars approval in Europe was established in 2003 and the first biosimilar was approved in the European Union (EU) in 2006. Although not a dramatic number, there are at least 22 biosimilars approved in the EU.
In the U.S., however, only a single biosimilar has been approved to date: Zarxio (filgrastim-sndz). Zarxio, marketed by Sandoz, Inc., a division of Novartis , is a biosimilar of Amgen ’s Neupogen. Zarxio, however, is not approved as an interchangeable biosimilar. That means, essentially, that the prescribing physician has to specifically prescribe Zarxio instead of Neupogen.
Amgen, in addition to litigation against Sandoz, is developing its own biosimilars. Amgen has submitted an application to the FDA for a biosimilar of AbbVie ’s Humira.
Of Celltrion’s biosimilar, the FDA wrote, “The results of the clinical development program indicate that Celltrion’s data support the demonstration of ‘no clinically meaningful differences’ between CT-P13 and the U.S. Remicade in terms of safety, purity, and potency in the indications studied.
CT-P13 is being studied in rheumatoid arthritis and a disease called ankylosing spondylitis, which can result in spinal vertebra fusing together. According to Bloomberg, Remicade created $4.45 billion in sales in the U.S. in 2015. Its primary competitor is AbbVie’s Humira.
CT-P13 has been sold as Remsima in the EU since 2013. Celltrion has a deal with Pfizer Inc. ’s Hospira division to market CT-P13.
Johnson & Johnson took a hit after the news on Friday. Shares traded on Jan. 29 for $104.44, dropped on the news on Friday, Feb. 5 to $100.54 and are currently trading for $101.17. The stock has been fairly volatile recently. Shares traded on Sept. 28, 2015 for $91.37, spiked to $105.25 on Dec. 16, and dropped to $97.50 on Jan. 19.
Damien Conover, an analyst with Morningstar, told Reuters that Celltrion’s Remsima and another Remicade biosimilar might hit the U.S. market in 2018, which could result in J&J’s Remicade losing half its sales by 2020. “The biggest potential damage could be to J&J, which has U.S. rights to Remicade.” He projects that Pfizer might pick up $500 million in annual sales of Remsima.
Other companies are trying to hack out a corner of the biosimilars market. According to analyst firm Raymond James, there are more than 60 biosimilars in development related to the anti-TNF mechanism used in Remicade, Humira, and Enbrel.