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Teva Sees Limited Competition For Biosimilar Market

By Peter Loftus Of DOW JONES NEWSWIRES Teva Pharmaceutical Industries Ltd. (TEVA) expects the fledgling market for so-called biosimilar drugs to be big, but the cost and complexity of developing them will limit competition, company executives said. Israel-based Teva and several other drug makers are developing new versions of existing biologics, which are large-molecule drugs derived from living organisms. Teva is testing a drug resembling Amgen Inc.'s (AMGN) Neulasta treatment for low white blood cell counts in cancer patients, which Teva hopes to begin selling in around 2013. "I don't believe it's going to be a crowded space," Teva Chief Financial Officer Eyal Desheh said in an interview this week at the J.P. Morgan healthcare conference in San Francisco. "It's a long and risky road to developing those." The field is different from Teva's core business of selling traditional generic drugs, which has heavy competition. Traditional generics are near-identical copies of small-molecule drugs, such as Eli Lilly & Co.'s (LLY) antipsychotic Zyprexa, and are easier and less expensive to develop and manufacture. Biosimilars are expected to be a big market, but developing and manufacturing them will be more complex and expensive, said William Marth, president and CEO of Teva's Americas unit, at the conference in San Francisco. "It will be much more difficult than what people think about when they think of generics," Marth said. He estimated that the cost of developing a single biosimilar would be about $200 million to $300 million, higher than earlier estimates of about $100 million. The cost to develop a generic drug is lower. On the flip side, prices for biosimilars are expected to be discounted more narrowly from the original drug, versus the steep discounts for generics. A clear regulatory pathway for biosimilars hasn't been finalized in the U.S., but it's likely to have tougher requirements than for traditional generics. For example, companies may have to run big clinical trials to prove that the safety and effectiveness of a biosimilar is comparable to the original drug. In contrast, generic pharmaceuticals can be approved for sale based on laboratory tests and other proof that they are equivalent to the original. Due to the barriers, many companies have formed biosimilars alliances to spread the cost and risk. Teva has a joint venture with Lonza Group (LONN.VX) to develop biosimilars. Amgen recently formed a biosimilar partnership with Watson Pharmaceutical Inc. (WPI), and Biogen Idec Inc. (BIIB) has teamed up with Samsung Pharmaceutical Industries Ltd. (001360.SE). Desheh thinks each original biologic may see competition from only two or three biosimilars. In contrast, some small-molecule drugs like cholesterol drug simvastatin have roughly a dozen generic versions. -Peter Loftus, Dow Jones Newswires; +1-215-982-5581; peter.loftus@dowjones.com

Stock News for Teva Pharmaceutical (TEVA)
DateTimeHeadline
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04/24/201208:26:02Watson, Actavis To Unveil EUR4.5 Billion Merger Deal Wednesday
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04/03/201202:15:49Glenmark Unit Gets US OK To Sell Copy Of Contraceptive Drug
03/29/201218:40:14US Court Rules For AstraZeneca's Seroquel XR Patent
03/29/201206:32:55Teva Revises Pricing On Euro 7-year Bond To Swaps +1.05 Area
03/28/201217:53:08Myriad Genetics Enters Testing Agreement With Teva Subsidiary
03/26/201204:57:02AstraZeneca Loses Bid To Delay Generics Of Seroquel In US Market
03/21/201212:59:07Drug Maker Watson To Buy Actavis For About EUR4.5 Billion - Source
03/21/201210:55:24Teva Pharmaceutical To Switch Listing To NYSE In May
03/14/201214:58:34Teva Receives FDA Approval For Generic Lexapro For Adults
03/08/201210:10:11Teva: FDA Approves Dose Counter For ProAir HFA Asthma Drug
02/21/201207:50:17Mylan 4Q Net Soars On Year-Earlier Items, Improved Margins
02/15/201212:54:13FDA Approves BioSante Gel for Male Low Testosterone; Shares Up

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