UPDATED: Amgen highlights late-stage pipeline, biosimilars in growth plan

CEO Robert Bradway R&D chief Sean Harper

Amgen's ($AMGN) brass rolled out their long-term growth plans for the biotech giant at a meeting in New York City today, talking up 8 programs with late-stage data readouts over the next several years and unveiling a "pick the winners" strategy that emphasizes human genetics in drug research to improve the odds of success. And even as the drugmaker and its peers seek legislative measures that would stymie biosimilars competition, Amgen itself aims to make the copycat biotech drugs a source of business growth.

Amgen plans to develop copycat versions of blockbuster biologics from other pharmas such as Roche's Herceptin, Eli Lilly's Erbitux and AbbVie's best-seller Humira, Forbes scribe Matthew Herper reported.

On the original drugs front, the Thousand Oaks, CA-based biotech powerhouse made an unexpected move in December to buy the pioneering genomics company deCODE for $415 million. Today R&D chief Dr. Sean Harper further explained how the capabilities of the company fit within the broader strategy at Amgen to be more discerning about which research programs to pursue. To hear Harper, Amgen is on the cusp of changing the way drug research is done and clearly wants to improve the odds of success in R&D along the way.

"Amgen is uniquely positioned to shape the future of biotechnology," Harper said in a statement. "Our new R&D strategy embraces a 'pick the winners' approach, which takes advantage of the knowledge we've gained from decades of experience and our industry-leading position in human genetics that has resulted from our acquisition of deCODE."

Everyone in biotech strives to pick winners, of course, yet Amgen clearly believes that the company gained an edge with the purchase of deCODE.

Wall Streeters, however, are likely more interested in Amgen's late-stage pipeline and programs. Between this year and 2016 the biotech company expects to reveal data from 8 late-stage R&D efforts. This year the company aims to unveil Phase III results for talimogene laherparepvec in melanoma and trebananib or AMG 386 for patients with ovarian cancer. Yet the biggest program on tap is Amgen's AMG 145, a PCSK9 drug for lowering cholesterol that the company plans to test in 26,000 patients, with results from four Phase III studies due out in 2014.

Four years out, Amgen CEO Robert Bradway foresees the beginning of a new revenue stream for his company from biosimliars. As Reuters reported, the chief executive aims to begin the launches of 6 such therapies in 2017. This comes as Amgen backs efforts for measures in a number of states to push for high standards for swapping out original biotech drugs with biosimilars, harping on the interchangeability issue. 

Amgen faces copycat competition to major products such as Epogen and Aranesp, so the strategy appears to be to throttle the knockoffs to its own drugs while investing in biosimilars that will hit the market after patents on competitors' therapies expire. To pull this off, it's relying on its decades of expertise in and large capacity for biologics development and manufacturing that few others can match.  

- here's the release
- see Reuters article
- check out Herper's post

UPDATED: With examples of biosimilars in Amgen's plans.

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