Court ruling opens up the US market to Remicade biosimilar
- Celltrion, a pharma company based in South Korea, has shipped the first batch of Remsima, its biosimilar form of Janssen’s Remicade (infliximab), to the US, where it will be marketed by Pfizer.
- The biosimilar was approved by the FDA in April 2016, but Johnson & Johnson filed a complaint in June 2016 to prevent Celltrion and Hospira from launching the drug. Remicade has patent coverage that lasts until September 2018.
- Celltrion CEO predicts that Remsima will be available in the fourth quarter of 2016.
Just a day after the ruling in the District Court for the District of Massachusetts that declared invalid Johnson & Johnson’s patent for its biologic for autoimmune disorders, Celltrion shipped the first batch of its Remsima biosimilar to the US. Remsima will be marketed in the US by Hospira, which is part of Pfizer. The overturning of the patent is likely to have a major impact on Remicade sales, with JPMorgan analysts predicting a decline of just over $1 billion in 2017. Celltrion expects Pfizer to have to continue to battle over the last few steps to the market.
Compared with Europe, the US is somewhat behind the biosimilars curve. The European Medicines Agency (EMA) launched its first biosimilars, epoetin alfa and epoetin zeta, in 2007. As of May 2016, there have been 20 biosimilars approved in Europe.
In contrast, as of July 2016, the US FDA had only approved two biosimilars. These are Celltrion’s Remicade biosimilar, and Zarxio (filgrastim), developed by Sandoz as a biosimilar to Amgen’s Neupogen. Others are also potentially on their way, with the US FDA’s advisors recommending the approval of Humira and Enbrel biosimilars.
Although the cost savings for biosimilars is small compared with small molecule generics (20-30% compared with up to 90% for some small molecule biologics), in these cash-strapped times even small amounts of money off high-priced drugs will be appealing to payers and providers.
Each approval in the US has led to a spate of stories talking about the influx of biosimilars to the US – but this has been slow to happen due to the combination of the newness and complexity of the legislation, the complexity of developing biosimilar versions of biologics, and the aggressive defense of their patents by the originator companies. The overturning of this case and the approach of other approvals may not mean that the floodgates are opening, but that there could be at least a growing trickle of biosimilars onto to the market.
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