Epirus confident to take slice of $3bn infliximab market; completes manufacturing milestone

By Dan Stanton

- Last updated on GMT

Epirus confident to take slice of $3bn infliximab biosimilar market

Related tags Monoclonal antibodies

Epirus is set to file its Remicade biosimilar in 2017 and says the $3bn market will remain a large opportunity despite growing entrants in infliximab development.

The firm’s candidate BOW015 is a monoclonal antibody against tumor necrosis factor alpha (TNF-α), and has already been launched in India​ as Infimab through its commercialisation partner Sun Pharma.

During a call yesterday to discuss third quarter results, Epirus announced it was on track to file the candidate – a biosimilar of J&J’s Remicade (infliximab) – in the US, Canada and Europe in 2017.

Hospira and Celltrion have launched infliximab biosimilars in Europe, while a number of other developers including Samsung Bioepis and Amgen are also developing versions.

And with some experts expecting the number of players in the biosimilar space​ to grow as barriers to entry drop and costs decrease, we asked Epirus whether over-competition will affect the profitability of its development.

“While there will be competition there will also be a large opportunity for biosimilars,”​ a spokesperson told Biopharma-Reporter. “Currently Remicade sales are estimated to be just shy of $9 billion.”

They continued: “Assuming around a 40% price discount and significant biosimilar penetration overtime, we estimate a biosimilar market opportunity of around $3 billion. Therefore even if there are a number of competitors, it is still a large opportunity for Epirus.”

In the Norwegian market​, Celltrion-made but Orion Pharma marketed Remsima is currently running at a 69% discount on Remicade, and in Denmark such large discounts have effectively wiped-out the presence of the reference biologic.

However, Epirus told us that overall average biosimilar discounts are around 25-35% of the innovator. “We do not anticipate the discounts to drop to a level where it would be too low to compete.”   

Manufacturing milestone

Epirus has also announced it has hit a milestone with completion of BOW015’s manufacturing process lock, supporting further the planned filing.

“Manufacturing process lock establishes product characteristics, therefore is an important milestone because a locked process can reliably produce product with appropriate product characteristics”

This process is specific to Epirus’ molecule: “Production starts in a bioreactor where the molecule is expressed in CHO cells that goes through various purification steps such as column chromatography and filtration,” ​and while the steps for monoclonal antibody production are “fairly standard,”​ it is the specific conditions which are proprietary.  

Related news

Show more

Related product

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...