Hospira, Celltrion achieve milestone in EU with OK for Remicade biosimilar

Hospira ($HSP), which jumped early into the the biosimilar market in Europe, has seen its efforts pay off with the approval of Inflectra, a biosimilar of Johnson & Johnson's ($JNJ) Remicade.

The J&J drug, which is approved for rheumatoid arthritis, Crohn's disease and several other conditions, had $2 billion in sales in Europe last year. Hospira has had biosimilars in the European market for 5 years, but Inflectra is Europe's first biosimilar of a monoclonal antibody (mAb) therapy and so marks a new milestone for the biosimilar market there. It was actually developed by South Korea's Celltrion, which Hospira partnered with in 2009 on an array of biosimilars. Hospira said it would roll out the drug in Europe "at the earliest opportunity taking into account any relevant patent protection."

"Inflectra offers physicians, patients and healthcare systems a more affordable treatment option, while maintaining similar quality, efficacy and safety to its reference product," Hospira Chief Commercial Officer Richard Davies said. "We are confident that with lower drug costs, Inflectra can provide an opportunity for European Union health systems to manage their budgets more effectively, supporting Hospira's commitment to provide patients with better access to high-quality, more affordable care."

This is a huge step for the industry, which sees the market for biosimilars holding great potential although it is fraught with difficulties. Hospira and Celltrion earlier this year halted work on a biosimilar of Roche's ($RHHBY) blockbuster Rituxan franchise. Exactly how large the biosimilars market will become is anyone's guess. IMS Health projects that biologics sales will surpass $200 billion this decade, from essentially nothing 10 years ago. IMS Health says the biosimilars market may be only $1.9 billion to $2.6 billion by 2015 but foresees it being the fastest-growing segment of biologics once the market takes hold.

A number of top-selling biologics, including Herceptin, Humalog, MabThera and Aranesp will lose product patent protection over the next 5 years. Many of these are blockbusters and have already been targeted by companies hoping to cash in on worldwide demand for life-extending biologics and the growing frustrations over the prices they command. Because of the complexities of creating biosimilars, they are expected to come at 15% to 30% discounts, rather than the 90% price cuts that often come with small molecule generics.

The biggest market will be the U.S., but it has yet to lay out the exact pathway that drugmakers will have to follow to get biosimilars approved. It also is expected to take a somewhat different approach than the European model of assuming there will be differences with biosimilars and having drugmakers show those differences don't matter.

The win for Celltrion also is sure to reignite speculation about interest by AstraZeneca ($AZN) in buying the South Korean drugmaker. Reports in July suggested the British drugmaker was sizing up Celltrion as a way to generate some additional revenue while it digs out from under patent losses.

- here's the Reuters story
- see Hospira's statement
- here's FierceBiotech's take

Special Report: Conquering the complexities of biologics to get to biosimilars

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