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Hospira Chalks up First EU Biosimilar Antibody Approval


By Cormac Sheridan
Staff Writer

Hospira Inc. has reached a major milestone in the development of the biosimilar drugs market by gaining formal European Commission approval for Europe’s first biosimilar monoclonal antibody, Inflectra (infliximab), which is based on the blockbuster TNF-alpha inhibitor Remicade (infliximab). It represents the first major dent in the armor of the biotechnology industry’s most valuable franchise.

“It really is a lighthouse event for the biosimilar industry,” Paul Greenland, vice president of biologics at Lake Forest, Il.-based Hospira, told BioWorld Today. ”We’ve also been able to get full extrapolation of indications, which was a question a lot of people had initially.”

Those indications include rheumatoid arthritis (RA), ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

It also has obtained the same international nonproprietary name (INN) as the reference product, which should ease its gradual adoption by the market. “Different INNs create confusion amongst the prescribers,” Greenland said.

Hospira’s rollout of Inflectra in Europe’s main markets will be delayed until February 2015, however. Earlier this year, Johnson & Johnson, of New Brunswick, N.J., obtained a six-month pediatric extension of its European patent on Remicade, following its submission of a new market authorization application containing data based on a Pediatric Investigation Plan. The patent originally was due to expire during 2014.

Hospira is unencumbered in several markets, however, including certain countries in Central and Eastern Europe, as well as some smaller western states, such as Norway, Ireland and Portugal. The rollout will commence in those regions, therefore.

The company has not issued firm guidance on pricing, but it will follow a similar strategy to the one it has pursued with its currently marketed biosimilars, Retracrit (epoetin zeta), which is based on the anemia drug Eprex (Erypo; epoetin alpha), and Nivestim (filgrastim), based on Neupogen (filgrastim).

“We need to get to a certain difference between ourselves and the reference product, to get to the point where payers and clinicians are comfortable with using a biosimilar,” Greenland said. It prices its current biosimilars at a discount of 20 percent to 25 percent with respect to the price of the reference product. “We don’t expect the infliximab market is going to operate much differently,” he said.

Hospira in-licensed the drug from Incheon, South Korea-based manufacturer Celltrion Inc., which last year obtained approval for the product in its home country, where it is sold as Remsima. Like Hospira, Celltrion gained a positive opinion for Remsima from the European Medicines Agency’s Committee on Human Medicinal Products (CHMP) in late June.

Celltrion has yet to disclose further progress, however, and rumors abounded Tuesday that it may be the subject of a buyout, owing to financial problems. “We feel quite comfortable that issue will not impact on Hospira’s agreement,” Greenland said. The companies’ alliance, entered in 2009, concerns eight biosimilar drugs in total.

Another contender in the fray is Boston-based Epirus Biopharmaceuticals Inc., which recently unveiled positive ACR20 data from a Phase III trial in rheumatoid arthritis of its biosimilar version of Remicade, BOW-015. It has set its sights on regulatory filings during the next year. (See BioWorld Today, Sept. 3, 2013.)

Inflectra, a chimeric human-murine monoclonal antibody, gained approval on the basis of data from a Phase III trial in 600 RA patients and from a Phase I trial in 200 ankylosing spondylitis patients. Those indications were picked as they were considered the most sensitive to any potential deviations from the profile of the reference product.

Greenland said he expects most sales to derive from new patients starting biologic therapy rather than those who are already on therapy switching to a cheaper product. Merck & Co. Inc., of Whitehouse Station, N.J., which markets Remicade in Europe, Russia and Turkey, reported sales last year of $2.08 billion.

Although the European Commission reportedly is concerned at what it perceives as the lackluster performance thus far of biosimilar drugs, Greenland questioned some of the market penetration statistics on which the commission based a recent report into the topic. According to the study, biosimilar versions of erythropoietin, human growth hormone (HGH) and granulocyte colony-stimulating factor (G-CSF) had, by mid-2011, captured just 12 percent, 7 percent and 18 percent of their respective markets. (See BioWorld Today, April 30, 2013.)

Greenland countered that there are not biosimilar products available for the various subcategories in each of these product areas, but where they are available, they have taken significant market share.

Biosimilar forms of G-CSF have more than 50 percent of Neupogen’s sales, he said, and biosimilar EPO drugs have around 30 percent of Eprex’s sales. At present, there are five biosimilar versions of EPO available in Europe, seven biosimilar analogues of G-CSF and just one biosimilar version of HGH.