The recent approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) of the first monoclonal antibody, Inflectra, represented “a major milestone for biosimilars in general,” according to Hospira CEO F. Michael Ball.
Discussing the company’s Q2 2013 results, Ball told stakeholders the positive opinion from the EMA “underscores the strength of [its] biosimilar programme,” which “will continue to be a key growth driver going forward.”
The firm expects a timeline of a couple of months for the market authorization review to take place by the European Commission, but once completed Inflectra – a follow on biologic of Johnson & Johnson’s rheumatoid arthritis drug Remicade – will become Hospira’s third marketable biosimilar.
Hospira launched Retrocit containing the active ingredient epoetin alfa (EPO) in 2008, and followed it up with Nivestim (filgrastim) two years later.
“In Europe, EPO and filgrastim were the 2 first biosimilars launched in the marketplace,” said Ball. “The market now has about 5 years’ worth of experience with those products, so I think the market is getting more comfortable with the idea of biosimilars.”
EMA spokesperson Monika Benstetter told this publication last month she “expects the steady stream of applications for biosimilars will continue.”
The company reported revenue for the quarter of just over $1bn (€776m), a minor decrease on the same period 2012, though operational income increased to $52.2m from a loss of $2.2m.
Novaquest’s $150m Investment in Hospira
So far twelve biosimilars have been approved in Europe whilst the US still awaits its first. However, in April Hospira received $150m of development funding from a partnership with Novaquest to bring EPO and filgrastim to the US, and a pegylated filgrastim biosimilar to global markets.
The total market share of these drugs is worth around $7bn, according to Ball, and the deal with Novaquest boosted Hospira’s biosimilar programme by allowing trials in parallel, therefore at the forefront of biosimilars with “the ability to access this $7 billion sooner.”
Inflectra-Maker’s Takeover Allegation
Inflectra is manufactured for Hospira by South Korean drugmaker Celltrion, and the two firms are working on a further seven pipeline biosimilars, including versions of Genentech’s cancer treatment Herceptin.
However, Bloomberg wrote on Wednesday that Pharma Giant AstraZeneca was looking to acquire Celltrion, an allegation that Celltrion said in a statement was “falsely reported.”
If Celltrion is acquired it will “only be good news” for Hospira, Ball said when questioned on any affects it may have on the relationship.
“What our focus is and the focus of Celltrion, or if they get acquired, the acquirer, is to take as much share as possible from the brand name biologic and convert it into biosimilars.
“There is lots of money out there for everybody, and I think we would do very well competing against anybody in that particular marketplace.”