Biosimilars were among the topics on the minds of attendees at the BIO CEO and Investors conference in New York earlier this week. The Biotechnology Industry Organization (BIO) has lobbied Congress for some time to grant innovators of biotech products a fairly long period—12 years, plus or minus—of exclusivity before follow-on products can be marketed. It was interesting, then, to hear the suggestion by Scott Gottlieb, Resident Fellow at the American Enterprise Institute and former Deputy Commissioner for Medical and Scientific Affairs, US Food and drug Administration, that FDA was likely to exert such stringent regulations on follow-on biologics as to make the exclusivity issue practically moot.
Evidence for that may be at hand already. Genzyme announced earlier this week that that it believes FDA will approve a new manufacturing facility in Framingham, MA, for its drug Myozyme, a biotherapeutic for a rare neurological disorder called Pompe disease. Approval to manufacture the drug in the new facility had been delayed over a year. The reason? Ostensibly, FDA felt the bioprocessing in the new facility would differ sufficiently from that of the existing facility as to produce a drug different from the one manufactured in the existing plant. In essence, the drug produced in the new facility would be treated as a separate entity. And to underscore this fact, Myozyme manufactured in the Framingham facility will be sold under the name Lumizyme.
If FDA is treating identical formulations manufactured with presumably identical processes in different plants operated by the same company as different drugs, then one has to agree with Gottlieb that differing formulations, manufactured by different companies using different processes will indeed face a long an arduous regulatory road—one that just might stretch out for, say 12 or so years.