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Amgen Running to Win in Both Lanes of Biosimilar Race


By Mari Serebrov
Washington Editor

Having pioneered the biologics pathway, Amgen Inc. is broadening its stride so it can sprint down both sides of the track in the biosimilars race, hoping to cash in on what it sees as a multibillion-dollar opportunity.

During a business review meeting Thursday, the Thousand Oaks, Calif.-based biotech gave investors a peek at its long-term strategy for building a competitive edge for its novel biologics and biosimilars. The discussion came as some of the company's strongest blockbuster brands are about to face stiffer competition in the U.S., as well as abroad.

In the well-traveled new biologics lane, Amgen is quickening the pace for developing novel drugs, which will serve as reference products for biosimilars of the future, and it's stretching the market for its existing biologics so they can keep ahead of the contenders.

To sharpen its edge with novel drugs, the company has developed an integrated modality platform that blurs the distinctions between small-, medium- and large-molecule drugs. While its passion is still biologics, Amgen recognized that two-thirds of disease targets are inaccessible to the larger molecule drugs, so it's expanding its focus to find the best way to target specific diseases.

Moving forward, the company's R&D will be driven by a "picking-winners" strategy rather than increasing the "shots on goal." The strategy involves a five-step process:

identifying therapeutic areas of interest;

identifying specific diseases in those areas;

identifying specific mechanisms applicable to those diseases;

identifying specific drug targets relevant to those mechanisms;

identifying or validating those targets using its human genetics platform.

In addition to bringing new brands into the race, Amgen is expanding into global markets such as China and Japan. It's also looking for ways to keep the track relatively clear for its existing brands, such as Neulasta (pegfilgrastim) and Aranesp (darbepoetin alpha). Part of a life-cycle approach, Neulasta and Aranesp are next-generation products of Neupogen (filgrastim) and Epogen (epoetin alpha), which have already lost patent protection in Europe and are about to lose it in the U.S.

Currently, Neulasta accounts for 75 percent of sales from the Neulasta/Neupogen global franchise, Tony Hooper, executive vice president of Amgen's global commercial operations, said at Thursday's meeting. In 2011, Neulasta had $4 billion in global sales, compared with $1.3 billion for Neupogen, which loses U.S. patent protection this year.

Although Neupogen is already competing with biosimilars in several markets, including Australia, Brazil and the European Union, Neulasta's near-term competition is from new drugs – not biosimilars, Hooper said. For instance, Teva Pharmaceutical Industries Ltd. is nearing the finish line with its new biologics lipegfilgrastim and balugrastim. They are long-acting granulocyte colony-stimulating factors that will compete with Neulasta, which will see its U.S. patent protection die in 2015.

Whether it's dealing with new drugs or biosimilars, Amgen is counting on a lack of product differentiation and experience in the market to create commercial hurdles for the competition.

Meanwhile, the biotech is preparing its own biosimilars through a partnership with Actavis Inc, formerly Watson Pharmaceuticals Inc. In addition to copies of Herceptin (trastuzumab, Genentech Inc.), Avastin (bevacizumab, Genentech Inc.), Rituxan/MabThera (rituximab, Biogen Idec Inc./Genentech Inc.) and Erbitux (cetuximab, Bristol-Myers Squibb Co./Eli Lilly and Co./Merck KgaA), which were announced last month, Amgen revealed Thursday that it's also working on Humira (adalimumab, Abbott) and Remicade (infliximab, Janssen Pharmaceutica NV). (See BioWorld Today, Dec. 21, 2011, and Jan. 29, 2013.)

Together, the reference drugs had a total in peak sales of nearly $41 billion. While Amgen didn't say which biosimilar is on track to be the first off the starting block in 2017, Remicade, with $5.5 billion in global sales in 2011, will lose patent protection in 2014 – the first of the six to do so.

According to the newest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies, Amgen could face a lot of competition in the biosimilar lane. At least 27 companies are pursuing rituximab biosimilars globally and at least 23 are chasing after trastuzumab. Adalimumab and infliximab are each being pursued by at least nine biosimilars.

To outpace the competition, Amgen is launching a campaign stressing its biologics manufacturing know-how. Praising the strategy, Deutsche Bank analyst Robyn Karnauskas noted that European concerns about manufacturing quality have been a factor in the slow pace of biosimilar uptake there.

Overall, Karnauskas was positive about Amgen's biosimilars plan, saying, "Even if they get a piece of the pie, that's an upside." She figured that every $1 billion in biosimilar sales would add $2.3 per share to Amgen's discounted cash flow.

However, the numbers might be half that for Humira and Remicade biosimilars, Karnauskas said, as the TNF inhibitors could compete with Enbrel (etanercept), which Amgen markets in the U.S.

Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.