“Other candidates are close,” said Kate Keeping, senior director of Biosimilars Research at Decision Resources Group. “Hospira has a biosimilar of erythropoietin-alpha expecting to file end of this year or the beginning of next year.
“Celltrion has an infliximab biosimilar with a potential patent issue – they’re challenging the 2018 patent expiry date [held by Johnson & Johnson].”
As for when the US will see its first biosimilar on the market, “The FDA hasn’t entirely committed to reviewing every biosimilar in 12 months – they have a staggered target for the proportion they will review within a year.” A biosimilar which files an application now could potentially launch by 2016, said Keeping.
FDA guidance: due
While wheels have begun turning on US biosimilar submissions, the FDA’s authorisation process is not yet fully clear, Keeping told BioPharma-Reporter.com.
“It’s well-documented that regulations in the US are some way behind Europe. A biosimilars pathway is one of the many topics the FDA is supposed to be drawing up documents on – there is a document intended to publish in fall this year.”
The legal framework for biosimilars in the US is defined by the 2010 Biologics Price Competition and Innovation (BPCI) Act, which legally enables companies to gain approval of a biosimilar.
“But to take it further and file for approval with the FDA, you need to understand what they require,” said Keeping.
“The FDA’s first guidelines in 2012 were reasonably detailed: they described the process, based on a totality of evidence which would enable you to gain approval for a biosimilar. But there’s no description of how you would gain approval of an interchangeable biosimilar – if you want to be more like a generic.”
Official rules on approving biosimilars are springing up in developing countries, but not in Russia and China, Keeping told us.
“An increasing number of developing markets are developing their own biosimilars pathways, either based on the EMA [European Medicines Agency] or the WHO [World Health Organisation]. Pathways are being rolled out in the developing markets of Brazil, Mexico and India.
“The big exceptions are Russia and China. Neither has established a designated pathway for biosimilars. That doesn’t mean they don’t have copy biologics, but they are approving them on a case-by-case basis, and not a rigorous head-to-head comparison. Until then, they can’t be defined as a biosimilar.”
Biosimilar makers: the hotspots
As for biosimilar manufacturing, research by Decision Resources Group found the big biopharma players – the European Union, US, and India – have between them 57 biosimilars currently in clinical trials.
Mexico, Russia, South Korea, Japan and Australiasia each have between seven and nine biosimilars in the works, while Latin America and Eastern Europe are also seeing some development activity. Canada, Africa and the rest of Asia are each working on a modest handful of biosimilars.
Globally, there are 280 biosimilars in the pipeline, and their clinical trials are increasing at a rate of 20% annually, said the research.