According to Boston-headquartered biotech firm Epirus, BOW015 received final marketing and manufacturing approvals from the Drug Controller General of India (DCGI) last week, making it the first version of Janssen’s rheumatoid arthritis monoclonal antibody drug Remicade tp enter the Indian market.
“We are now able to deliver a high quality product to patients who may not be able to afford current treatment options,” said CEO Amit Munshi. “We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets.”
In January this year, Epirus entered a commercialisation partnership with Ranbaxy Laboratories, but the manufacture of the biosimilar has fallen to fellow Indian drugmaker Reliance Life Sciences (RLS) from its facility in Mumbai which was inspected and approved in July.
RLS offers contract manufacturing services for recombinant proteins and monoclonal antibodies (both mammalian and microbial cell culture) but also has its own biosimilar portfolio with eight drugs currently marketed in India and overseas.
Fujifilm in Europe
Epirus has signalled its intention to bring BOW015 to Europe, but - unlike in India – it will not be the first to challenge Janssen’s market dominance as Hospira and Celltrion’s Remicade biosimilars Inflectra and Remsima were approved in July 2013.
However, Epirus does not intend to use RLS for the commercial manufacture in Europe, a recent SEC filing said, instead opting to use its own manufacturing platform Scale in partnership with the CMO Fujifilm Diosynth Biotechnologies.
“We believe that our relationship with Fujifilm will allow us to expand future capacity and provide a back-up secondary manufacturing site,” and while RLS will provide supply for India and other territories where Ranbaxy or another commercialization partner acts as distributor, “for Europe, we plan to supply product directly from Fujifilm.”
Shift to single-use
The filing also spoke about Epirus’ deal with Fujifilm to shift its Scale platform “from traditional stainless steel manufacturing to single use disposable systems,” which, due to its modular nature, is being offered as a manufacturing technology in emerging markets.
“Investment into a Scale facility can range from $20 million to $40 million for a facility that, once up and running, could produce up to 150 kilograms per year of biologic material,” the firm said, adding a Scale facility can easily manufacture multiple biologics.
“Single-use bioreactors enable smaller production runs and facilitate operation of a multi-product facility that is well suited to the evolving market for biologics. Once the market demand exceeds the production output of a single bioreactor, additional equipment can easily be ordered and installed.”
Fujifilm, like a number of biologics makers, is a strong advocate of single-use technology having recently invested in two 2,000L disposable bioreactors at its plants in the UK and US.
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