Herceptin

8. Herceptin
The company: Roche
Worldwide sales: $6.56 billion

Roche's Herceptin was the pioneer drug in its HER2 breast cancer franchise, which has expanded quite a bit as of late. On its own, sales of the drug grew 6% for the Swiss pharma ($RHHBY) last year, largely due to a 9% increase in U.S. sales and an 11% spike in so-called international sales, which include countries in Eastern Europe, the Middle East, Africa, Latin America and elsewhere. Roche saw particularly strong Herceptin growth in China, with access programs and testing initiatives cuing a 40% sales hike, and in Brazil, where availability of Herceptin on the national public healthcare system drove sales up 10%.

Herceptin also got a regulatory boost with European approval for a subcutaneous formulation of the drug in June 2013; that version has launched in markets including Germany and the U.K.

But Herceptin is no longer alone in Roche's HER2 lineup. Roche now fields a trio complete with Perjeta, a Herceptin add-on treatment that last year bagged a historic pre-surgery indication, and Kadcyla, which some were calling "Super-Herceptin" before its 2013 debut on the market. Together, the group's sales rose 14% to reach 6.6 billion Swiss francs ($7.56 billion) last year.

Roche can use Perjeta and Kadcyla's new revenue streams with biosimilar competition for Herceptin just around the corner. Back in August, India pulled divisional patents on the drug, citing improper submission--and Roche decided not to pursue them. But just when Mylan and partner Biocon were ready to launch their version, Roche made it clear it was not so welcome, suing the pair as well as the Drug Controller General of India (DCGI). Approval from the DCGI came too quickly for the generics makers to have followed India's 2012 guidelines for launching biosimilars, Roche claimed.

For more:
Special Reports: Top 15 Drug Launch Superstars - Kadcyla - Roche/Genentech | An ominous trend resurfaces as new drug approvals plunge in 2013 - Kadcyla
Roche legal action messes with Mylan's India launch of its Herceptin biosimilar
Roche highlights strong 2013 sales of cancer drugs, vows to boost dividend
India hits Roche's Herceptin in latest blow to Big Pharma patents
Roche bucks generics-erosion trend with 4% sales hike

-- Carly Helfand (email | Twitter)

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Herceptin