US made biosimilars: Competitive advantage or marketing spin?

Coherus says American healthcare providers and payers favor biosimilars made in the US over those made overseas. But an industry analyst has dismissed this saying location should not matter provided the facility is approved.

Coherus’ second quarter 2018 contained several regulatory milestones relating to its candidate Udencya (pegfilgrastim-cbqv), a biosimilar candidate to Amgen’s Neulasta. A resubmission to the US Food and Drug Administration (FDA) was accepted in May, while in July Europe’s Committee for Medicinal Products for Human Use (CMPH) gave the biosimilar a positive opinion.

Coherus is not alone in developing pegfilgrastim biosimilars. Other firms including Sandoz and Pfenex are looking to tap a market worth close to $5 billion (€4.3 billon), though all have been pipped to the post by Mylan, which saw its biosimilar Fulphila approved in the US in June.

With such market conditions, Coherus has regularly stated it holds a competitive advantage in the US due to Undencya being made domestically.

The drug substance is made in Boulder, Colorado by third-party manufacturer KBI Biopharma. Fill/finish and packaging takes place at two other US-based facilities, run by undisclosed contract manufacturing organizations (CMOs).

“We are quite proud that this is a Made in the USA product,” COO Vince Anicetti reiterated in the recent financial call (transcript here).

Marketing spin?

But why – BioProcess Insider asked – would the manufacturing location of an approved biosimilar be a differentiator?

“Payers don’t give a crap where a biosimilar is made – and I’ve spoken to lots of payers,” a biosimilars market commentator who asked to remain anonymous said.

“If the FDA has approved it, it’s all good. Saying that a biosimilar made in the US is ‘better’ than a biosimilar made in Europe or India comes across as desperate marketing spin.”

Market research

Coherus disputed these views and said internal market research demonstrates American-made products will fare better.

CFO Jean-Frédéric Viret told us the firm had undertaken two surveys with healthcare providers, all of which said products being made in regulated markets – Europe or the US – is desirable when looking at which biosimilars to adopt. And for US healthcare providers, a US location was a further plus as “some of the large clinics and hospitals expressed a desire to actually come and visit the facility,” he said.

“Before [healthcare providers] switch, they want to make sure that there won’t be a supply issue,” Viret continued. “Their biggest fear is to be locked into a contract, say with us, and then there’s disruption in supply. They would have to go and then buy the originator product and lose the financial benefits.”

It is a similar case for the payers, Viret said. “Some of them will want to inspect the place. The fear here is that they put something on formulary and all of a sudden there is no supply.”

Quality checks

Our source conceded US-made biosimilars could have an advantage under a protectionist push coming from the White House, including changes in tax rates and Donald Trump’s belief that US-made products will “make America great again.”

But Viret disputed this, saying “it’s nothing to do with any tax breaks coming from Washington. It’s really got to do with people being burned before buying supplies ex-US.”

And having a facility approved through inspections is one thing, but staying compliant over a long period of time is another, he continued. “It’s easy enough for a company to stumble, and then it’s hard to get back on their feet.”

And thus with a US facility an hour-and-a-half away (in the case of Coherus’ HQ in California and KBI’s facility in Colorado), Coherus can constantly and easily keep tabs on its manufacturing quality, Viret added.

More pegfilgrastim approvals over time may show whether a US-made product is a differentiator in an increasingly busy marketplace. But in a poll taken by this journalist in 2017, albeit for his previous publication, only 30% of 118 respondents believed American-made biosimilars will be more successful than products manufactured elsewhere.