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.”
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.