As reported in Bloomberg, the FDA's Margaret Hamburg said the agency would be issuing its guidelines for biosimilars in "the very near-term time frame." The FDA is weighing how extensive the clinical trials should be to judge whether biosimilars work the same as the licensed reference product. At present, since no rules for biosimilars exists, companies who wish to introduce a copy of a biologic with an expiring patent are filing BLAs. BLAs are more time-consuming and expensive than the pathway the FDA is expected to propose for biosimilars.
The Congressional Budget Office estimates that biosimilars once approved will save in aggregate $25 B per decade for consumers. A spokesman for Teva, a leading biosimilar company, says th enew rules are critically needed so his company can stop filing BLAs to access the US market. Teva is known to be working on biosimilars for Amgen's Neulasta and Roche's Rituxan.
In developing its biosimilar rules, the FDA is considerng user fees to expedite the review of biosimilar applications. These would be on the order of $1.5 M and would allow the filing company to seek FDA advice during development and result in "timely consideration" as to whether their product could be automatically substituted for the reference.
Analysts still expect only the companies with deep pockets to pursue biosimilars at first as both clinical trials and user fees are expected. The list of companies often includes Sandoz, Teva, Hospira and Actavis as among the better funded biosimilar producers.
Posted by Bruce Lehr Feb 26th 2011.