Reader's poll

American-made biosimilars a differentiator in US market, Coherus

By Dan Stanton contact

- 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."

And now we look to you, our loyal Biopharma-Reporter readers, for your views on this issue. Feel free to leave a comment and to answer the following questions:

The poll is now closed

Related news

Show more

Related products

show more

dPCR Case Study

dPCR Case Study

CellCarta | 08-Aug-2022 | Case Study

Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring...

The Reagents Behind Much of Molecular Biology

The Reagents Behind Much of Molecular Biology

Thermo Fisher Scientific | 25-Jul-2022 | Case Study

The ability to amplify, modify and fabricate DNA is fundamental to modern molecular biology. Why do so many researchers take their constituent parts for...

Microsampling in Early Phase Drug Development

Microsampling in Early Phase Drug Development

Altasciences | 10-May-2022 | Technical / White Paper

Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic...

Seasonal Vaccine Manufacturing

Seasonal Vaccine Manufacturing

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...

Related suppliers