The new drug by Teva Pharmaceutical Industries for driving up the production of white blood cells has been approved by the Food and Drug Administration. The drug is similar to Neupogen, which is produced by Amgen Inc. Neupogen is sold in the U.S. market and its patent is supposed to expire in the coming year. Teva had previously agreed not to bring its drug in the market till next year, as Amgen’s drug patent is going to be there till the end of 2013.
The drug is used to boost up the production of white blood cells, which provide immunity to the body. They are destroyed by the chemotherapy that is given to the cancer patients and therefore such drugs are prescribed to bring their level of white blood cells to the normal level. The drug is hence very important for developing the resistance to the infections that attack when the immunity is weak in a person.
The drug by Teva called tbo-filgrastim is going to compete with Neupogen. However, according to analysts they are not perfect substitutes.
"While approval at this time is somewhat unexpected, we note the two drugs are not substitutable, and it will require a launch ramp and extensive marketing efforts by Teva to gain share," RBC Capital Markets analyst Michael Yee said, as reported by Yahoo News.
The new drug by Teva is being sold outside the United States and gaining share in the market, but for the U.S., the major share is still with Amgen, which has huge sales of Neupogen. The two drug producers are now about to come directly in competition with each other after the approval by FDA.
The approval of biosimilars for the already-present drugs is a very sensitive issue, as the new drugs are produced through a complicated process. Their testing is done extensively before launching them in the market. FDA also has to take into consideration such issues while giving approval for the new drugs. Patent issues are also supposed to be settled with the producers of the drugs.
Amgen is not expected to lose its market share to a great extent, even after the Teva drug is introduced, as the experts feel they can both stay in market at the same time without having severe competition. The sales for Amgen are not expected to drop after the new entry and the company is expected to continue to earn revenues.