- 18Oct
Making a new move into the fledgling market for generic biotech drugs, pharmaceutical giant Pfizer has acquired worldwide rights to sell human insulin and insulin analogs being developed by Biocon, one of India’s largest biotech companies.
Under the terms of the deal, announced Monday, Pfizer will pay Biocon $200 million initially and up to $150 million in additional payments. Biocon will manufacture the diabetes drugs for Pfizer.
The deal is the latest sign of interest among traditional pharmaceutical companies like Pfizer in expanding into the market for biologic drugs, which are made in living cells rather than chemical factories. These drugs often sell for high prices and have been immune to the sudden onslaught of generic competition that can eviscerate sales of a chemical drug once its patent expires.In addition to trying to develop novel drugs, some of the companies hope to also sell their own versions of existing biotech blockbusters, such as insulin, the anemia drug erythropoietin and big-selling rheumatoid arthritis drugs like Amgen’s Enbrel.
Pfizer rival, Merck, for instance, has a business unit dedicated to these so-called “biosimilars,’’ as these drugs are sometimes called because they are not, strictly speaking, generic. Lower-priced biologics could save the health care system billions of dollars a year, and the health care reform law enacted earlier this year requires the Food and Drug Administration to develop a system for approving such biosimilar drugs.
“We view this Biocon partnership as a very strong foundation stone in our biosimilar strategy,’’ David Simmons, president and general manager of Pfizer’s established products business unit, said in a news conference Monday.
Mr. Simmons said Pfizer decided to obtain its product from Biocon, rather than develop its own, because the Indian company was “clearly in the lead in bringing these products to market.’’ The agreement would also help expand Pfizer’s sales in emerging markets, which is also a priority for drug companies as sales growth slows in the United States, Europe and Japan.
Kiran Mazumdar-Shaw, the managing director of Biocon, said her company’s low-cost manufacturing in India would give Pfizer an advantage in the market.
Biocon has already won approval for its generic insulin in 27 developing countries. Mr. Simmons said Pfizer and Biocon hope to have the product approved for use in Europe in 2012 and in the United States by 2015 or 2016.
Pfizer will also have rights to copycat versions of three so-called insulin analogs being developed by Biocon. Analogs are slightly modified versions of insulin that either last longer in the body or act more quickly. They are often bigger sellers than the basic insulin itself.
The analogs would be imitations of Sanofi-Aventis’s Lantus, Novo Nordisk’s Novolog and Eli Lilly’s Humalog.
Biocon’s version of Lantus, known generically as insulin glargine, is already on sale in India. Ms. Mazumdar-Shaw said the company hopes to be ready to introduce the products in Europe and the United States when the patents on the original drugs expire from 2015 to 2017.
One reason biologic drugs have not been subject to generic competition is that they are more complex than chemical drugs, making it more difficult to demonstrate that a copy is truly the same as the original branded drug.
But with patents now expiring on the first generation of biotech drugs, such as insulin and the anemia drug EPO, or erythropoietin, governments in Europe and the United States are trying to introduce biosimilars to save money.
The F.D.A. is holding a public meeting on Nov. 2 and 3 in Silver Spring, Md. to seek input on how to set up the pathway for approval of the near-generic biologic drugs.
Mr. Simmons of Pfizer said Monday that since the pathway for biogenerics has not yet been established, Biocon plans to conduct a phase 3 clinical trial of its insulin and to seek approval under an existing pathway known as rule 505(b)(2).
