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AbbVie seeks to head off Humira biosimilar impact with new drug launches

AbbVie Inc.'s Chairman and CEO Richard Gonzalez is not fazed by the upcoming entries of biosimilars for its flagship product Humira, the world's best-selling medicine.

"We're raising our guidance despite the anticipated introduction of direct biosimilar competition in certain markets outside the United States in the fourth quarter. So clearly, we expect our performance in the second half of the year to continue to be robust," Gonzalez said on the company's July 27 second-quarter earnings call.

Responding to an analyst question regarding the launch of Humira biosimilars in the EU, Gonzalez said the company had already anticipated and has planned for this scenario, adding that "it is playing out exactly as we had planned it to play out."

Gonzalez also said AbbVie plans to introduce more than 20 new therapies or major indications from its late-stage pipeline before the launch of direct biosimilars in the U.S., as it aims to head off the impact of the competing drugs and diversify revenue sources.

Among these new therapies, upadacitinib is being developed to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis and psoriatic arthritis, and risankizumab is being evaluated to treat inflammatory diseases, including psoriasis, Crohn's disease and psoriatic arthritis.

The company is also working to expand the usage of its cancer therapies Venclexta and Imbruvica, as well as women's health drug Orilissa, which was approved earlier this week.

Looking at 2019 and 2020, Gonzalez said the company will have assets including Humira, Imbruvica, Mavyret, Venclexta, Orilissa, upadacitinib and risankizumab, which "will all either be multibillion-dollar assets or on their way to being multibillion-dollar assets."

"By 2020, AbbVie will be extremely well positioned with multiple new assets in our portfolio, driving growth, enabling us to continue to achieve our mission of delivering top-tier industry performance," Gonzalez added.

Humira recorded $5.19 billion in global sales for the second quarter. It is approved to treat certain inflammatory and autoimmune disorders, including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.

In July, the U.S. Food and Drug Administration unveiled a new set of actions aimed at speeding biosimilars to the U.S. market. There are 12 biosimilars that have been cleared by the U.S. regulator, but only a few are on the American market — mostly because of ongoing patent disputes.

However, the European Medicines Agency has continued to recommend biosimilars at a more effective speed than the U.S. FDA.

Earlier on July 27, the EMA recommended Mylan's Hulio, a biosimilar of Humira, for approval. In June, the EMA recommended the approval of Novartis AG's copycat versions of Humira — Halimatoz, Hefiya and Hyrimoz, which too are biosimilars.

AbbVie has agreements in place with Amgen Inc., Biogen Inc. and Samsung Bioepis Co. Ltd. as well as Mylan NV that allow the companies to launch their biosimilars for Humira in the U.S. in 2023.