In the US, a Food and Drug Administration (FDA) advisory committee voted overwhelmingly in favour last month of the monoclonal antibody biosimilar CT-P13, leading to its marketing authority holder Pfizer to predict a launch date later this year.
Meanwhile across the pond, Inflectra - marketed by Pfizer acquisition Hospira - and Remsima - marketed by a number of pharma firms from Napp Pharmaceuticals in the UK, to Orion Pharma across Scandinavia - became the first biosimilars of J&J’s autoimmune blockbuster Remicade to be launched in major European markets last February
What all these products have in common is that they are manufactured by Celltrion, which also has global infliximab supply deals in place with firms including Egis, Hikma, Perrigo, Nippon Kayaku, and BioGaran.
A spokesperson from the South Korean drugmaker said Celltrion has “one of the world's largest biologic manufacturing facilities” at its mammalian cell culture site in Incheon City.
The plants have a total production capacity of 140,000L through four 12,500L lines and six 15,000L lines, and the firm has a planned expansion which will add a further 90,000L of capacity for its commercial biosimilars.
Safe storage
According to Celltrion’s latest financial statement, the products are sold to “related party” Celltrion Healthcare which sells it on to its distribution partners – including its own sales and distribution subsidiary Celltrion Pharm.
However, under the agreement a certain amount of product sold is stored by Celltrion itself.
The firm did not provide Biopharma-Reporter with production figures, but the spokesperson said the "proportion of Remsima and Inflectra produced at its plant is dependent on their demands," and protocols have been set up to ensure minimal risk in the stockpiling of infliximab.
“Celltrion Healthcare's partner companies handle supply chain management systems and they have proper licenses and facilities. In order to ensure the product quality, Celltrion also routinely monitors the process.”
They added: “Given that the product's shelf life is 60 months, it can be said that there is little or almost no risk of product shortage.”
Fabricated sales?
Celltrion’s biosimilar storage and sales strategies were attacked last month in a research report accusing the firm of fabricating its revenues by offloading unwanted product to Celltrion Healthcare.
The authors Ghost Raven Research claim Celltrion Healthcare was been “set up for no other purpose than to allow Celltrion to fabricate sales and hide excessive levels of debt and inventory.”
Little is known about Ghost Raven Research, which claims to represents an anonymous team of researchers and forensic investigators.
“The true financial picture is that Celltrion is a tiny company burning tons of cash, with way too much inventory and way too much debt,” the report said. “Were Celltrion to report accurate financial statements, we believe it would collapse as one of the largest frauds in world history.”
Celltrion responded earlier this month, pointing to the report’s disclaimer that states it should be assumed Ghost Raven Research along with its clients will profit from a decline in the company’s share price.
“Our product, Remsima, the world’s first monoclonal antibody biosimilar, has been officially approved in 70 countries and is selling in the global market through reliable partner companies such as Pfizer and Mundi Pharma,” Celltrion said in a statement.
“We believe that the short sellers of Celltrion stocks must have taken huge losses, and they are circulating these false reports to recover their damages.”
The original article said Inflectra launched several days before Remsima in EU markets. Both treatments were actually available and being used in European markets before the launch press releases were issued by the companies (Hospira and Celltrion). The releases announced the availability in the major European markets once the final patents had expired. Technically they both launched at the same time as they are the same product.