Reader's poll

American-made biosimilars a differentiator in US market, Coherus

By Dan Stanton

- Last updated on GMT

Image: iStock/MichellePatrickPhotographyLLC
Image: iStock/MichellePatrickPhotographyLLC

Related tags Etanercept

US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?

The first biosimilar product was launched in the US in 2015. And while there are currently four approved, this number is expected to skyrocket over the next few years.

Take AbbVie’s Humira (adalimumab), for example: over 30 companies​ are developing a biosimilar version of it, chasing a market worth over $16bn annually, $10.4bn of which comes from the US.

Therefore companies have looked to a number of variables to differentiate their product in a potentially crowded marketplace. These range from the speed to market​ and heavy price discounts​, to physician/patient educational efforts​ and potentially even brand name marketing​.

But in a results earning call this week, Coherus Biosciences CEO Denny Lanfear said his company has conducted research showing providers and patients prefer a biosimilar manufacturer in the US.

Biopharma-Reporter contacted the firm, and while spokesman Patrick O'Brien would not share this research, he said the firm believes having an American-made product will make a difference in the US marketplace.

Coherus – which is developing versions of Amgen’s Neulasta (pegfilgrastim) and Enbrel (etanercept), as well as an adalimumab biosimilar – uses contract manufacturing organisation (CMO) KBI Biopharma to make its products.

The CMO, while owned by a group of Japanese companies​, operates four facilities in the US: Durham and Research Triangle Park (NC), Boulder (CO), and The Woodlands (TX).

But we also contacted Novartis subsidiary Sandoz, makers of the first US biosimilar Zarxio (filgrastim) and the largest biosimilar developer by revenue. The firm has three dedicated production sites for its global biosimilar products, two in Austria, one in Slovenia, but none in the US.

And while spokesman Chris Lewis would not comment on other people’s perceptions about potential stakeholder preferences, he told us:

 “We sincerely hope any decisions related to manufacturing sites will be made based on the quality, excellence and scientific expertise demonstrated by those sites, not on factors such as location.”

An official from another biosimilar developer told us: "The location of manufacturing may matter from a political perspective [President Trump has pledged to bring drug production back to the US​]​, but when it comes to earning stakeholder trust around product quality, the things that matter most to physicians are clinical and post-market data which show how well a drug works for patients.

"Ultimately, individual biosimilar products will win on quality and affordability, not on nationalistic whims."

Related news

Show more

Related products

show more

Process optimization for mAb commercial manufacturing

Process optimization for mAb commercial manufacturing

Content provided by Catalent | 01-Jun-2023 | Product Presentation

Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring...

Related suppliers