At a recent press event hosted by contract manufacturer SAFC, the topic of biosimilars came up in a few presentations by the company’s executives. Almost all of them cited the recent Wall Street Journal story on the expected delays and obstacles facing biosimilar developers. But the consensus seemed to be that the market for biosimilars is not going to be like the generics market.
The biosimilars market is expected to be about $2bn (EUR1.5bn) by 2015, which means it’s “yet to be close to relevant,” Gilles Cottier, president of SAFC, said. By comparison, global sales of biologics are projected to eclipse $200bn by 2016.
Executives also said it’s likely the market will be controlled by the major biopharmaceutical players, such as Roche and Amgen.
The “jury is still out” on how the biosimilar market will shape up, especially in the US – the world’s largest market, Cottier told Outsourcing-Pharma, but he added that if he was “going to place a bet,” he would say the “existing, larger biopharma players that are entering the biosimilar space, as well as continuing in the innovative space, probably have a better chance because of the complexity of the IP, the complexity of the processes and the complexity of making a biosimilar.”
He added: “And especially as the larger players are deciding – and some are already -- to invest with a manufacturing footprint in emerging markets, not only will they have the depth and breadth of knowledge to make” biosimilars, but they also will have the infrastructure and the labour costs under control.
SAFC estimates that between 860 and 870 biolosimilars are in development, but those numbers are small compared to the patented biologics that are in development and currently on the market.
Biosafety Testing for a Head-Start
And although the US FDA has yet to clarify exactly how biosimilars will be approved in the world’s largest market, biosimilar developers are already beginning to test their prospective products for contamination and other details.
“We’re working with numerous companies focused entirely on biosimilars,” as well as major companies starting to have biosimilar efforts that are looking to test their manufactured cell banks, Michael Garrett, senior director of global marketing at BioReliance, told us.
“The US pathway has not been well established” yet, but “if you’re a savvy company and you know things will work their way out in the US” to support the development of biosimilars – “you wouldn’t want to go back to figure out if your product meets the testing” specifications, Garrett said.
A lot of biosimilars are currently being made for less regulated markets, and a lot of those companies would like to use the data collected from the local markets as their clinical trials, he added.
Whether it’s a branded product or biosimilar, developers will have to go through the same testing processes on the upstream and downstream ends, Garrett said, noting that companies are beginning to approach BioReliance as they transition between less-developed markets and would like to ensure their products satisfy certain test requirements for the US and EU markets.