Amgen sales up for the quarter, but biosimilars grab buzz

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Amgen's first-quarter revenues were up 5% over last year to $4.2 billion, with particular strength provided by biologics Enbrel, Xgeva and Prolia. The company's nascent biosimilars pipeline drew a significant amount of interest during the Q&A that followed a nearly 25-minute financials presentation.

The gist: what are you doing and what do you know?

The answer: it's not so much complicated as hard to explain, since the FDA has yet to provide a clear roadmap for how drug makers can navigate the field. That said, Amgen is plowing ahead, and the company said it expects to start a head-to-head comparison this year between Roche's Herceptin and their own biosimilar formulation of the drug through Actavis. The company also said it expects to commercialize around six biosimilars.

“We've been having a lot of discussion with regulators around the world about this topic [of] biosimilars, given our expertise,” Amgen's R&D president Sean Harper said during Tuesday's earnings call. Harper said a major difference between the undefined US market and Europe is that thought the FDA has provided way-finding tools, Europe is far clearer, having category-based biosimilars requirements, whereas the FDA guidance currently puts all biosimilars in the same requirement pool.

The company also said it was pursuing a Herceptin lookalike because, even though taking a novel approach could provide a revenue benefit, there is still an opportunity to be had in the well-trod market, from both a reach and access perspective. The company said it was too early to predict when data from the Herceptin-biosimilar face-off would be available.

The company said it expects to have news—both in terms of FDA registration and data call-outs—for eight agents this year, and will present clinical trial information about its experimental oncology drug T-Vec (talimogene laherparepvec) at the June ASCO conference. Phase III results for ovarian cancer medication trebananib are expected by the middle of this year.

Sales leaders for the quarter included arthritis shot Enbrel, which rose 11% over the same period last year, to $1 billion; Xgeva, an injectable for cancer which saw sales skyrocket to $223 million, a 46% increase over sales for the same period last year; and bone drug Prolia, which saw sales rise 61%, to $142 million.

EVP of global commercial operations Tony Hooper said the company will continue to pour money into Enbrel and that the company is “confident in its continued growth potential.” Although Epogen (anemia) sales slid 2%, the company said a recent competitive change is working in its favor, and that the company left 2012 with Epogen controlling 96% of the market. One headwind was removed when Affymax was forced to pull its Omontys product in February after several deaths and allergic reactions.

Additional movers during the quarter were Prolia, which execs said had “seasonal softness” but has had a recent uptick since the company began re-running its Blythe Danner ads on television. Hooper said that patients generally received Prolia 90% of the time it was requested, and that Xgeva, which uses the same active ingredient but in a different dosage for prostate cancer, is increasing its global share.

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