Inflectra received the marketing approval following the regulatory nod from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) in June, making it the fourteenth biosimilar to reach the European market, and the first monoclonal antibody (mAb) biosimilar.
However, though acknowledging the success in the EU, Hospira is looking towards the US - who is yet to have approved any biosimilar products – as a major opportunity for biosimilars, according to Hospira spokesman Dan Rosenberg.
He told Biopharma-Reporter.com: “The US is the largest pharmaceutical market in the world, and, in the long run, represents the biggest opportunity for these products from a revenue perspective.”
Citing the Affordable Care Act of 2010 as establishing a biosimilar pathway in the US, he said he was “confident Hospira will be among the first entrants into the U.S. biosimilars market, which [Hospira] expects will be sometime around mid-decade.”
Furthermore, the US Food and Drug Administration (FDA) has been developing guidance to support the implementation of future biosimilar products, and therefore, Rosenberg said, “with biosimilars, it’s not a question of if, only of when.”
Pipeline at the Ready
Late last month, the US biosimilar programme received a blow when the Californian assembly passed Senate Bill 598 which aimed to restrict biosimilar use once on the market. Though this example is a State-wide success for branded biologics firms, the FDA told this publication efforts to undermine biosimilars remained “worrisome.”
Therefore we asked Rosenberg if Hospira had invested in a sector that may not open up as quickly as predicted. “While we always prepare for contingencies, we don’t have concerns about the U.S. market not opening to biosimilars.”
Rosenberg’s words echoed those of Hospira CEO Mike Ball, who, speaking yesterday at the Morgan Stanley Global Healthcare Conference in New York, said the US biosimilar market in the US is “certainly not fiction.”
In the context of current sales of the reference products, Hospira has a biosimilar pipeline of $40bn over the next decade, he continued, and with multiple biosimilars already approved in the EU and Australia it “will position [Hospira] favourably when the US market forms.”
Furthermore Hospira is poised to take advantage with a five year development gap on any new players i, Ball continued, adding “there are huge barriers to entry,” for any companies keen to get into the biosimilar sector.
Hospira’s share price rose by 2% following the announcement yesterday.
Inflectra (infliximab) - manufactured by South Korean-based biopharmaceutical company, Celltrion and marketed in the EU by Hospira - is a biosimilar medicine to the reference medicinal product, Remicade, developed and marketed in the US by J&J subsidiary Janssen.
According to Janssen’s end of year report, Remicade for the treatment of multiple inflammatory diseases was the firm’s topseller clocking worldwide sales of $6.1bn, with over $3.5bn in the US alone in 2012.
Following the approval, Brian Kenney, a Spokesman from Janssen, told Biopharma-Reporter.com: "Janssen has long supported a defined pathway for biosimilars that ensures patient safety and expands access to these medicines."
Celltrion Seeks Japanese Approval
In Remicade-related news, Celltrion announced today it had completed the filing procedure for approval of its Remicade bioequivalent, Remsima (developed with Japanese firm Nippon Kayaku), in Japan, a market the company said was the second largest for Remicade outside the US.
An official from Nippon Kayaku said in a statement: “As Remsima has already successfully received approval from the EMA, the approval process in Japan is expected to proceed smoothly.”