Abstract
After much anticipation, approval of the first U.S. biosimilar medications may be around the corner. Biosimilars hold the promise of reducing healthcare spending by offering lower-cost alternatives to high-priced biologic drugs. Biosimilars are not generic versions of existing biologics, however. Generic medications contain an active ingredient identical to that in the reference (“brand-name”) product. A biosimilar may contain an active ingredient slightly different from the reference product, as long as the differences are not clinically meaningful. The Food and Drug Administration (FDA) describes a biosimilar as highly similar to the reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product.[1].
Highlights
After much anticipation, approval of the first U.S biosimilar medications may be around the corner
The Biologics Price Competition and Innovation (BCPI) Act requires an applicant to disclose the application and its contents to the sponsor of the reference product within twenty days of filing the application[2]. This will enable the sponsor of the reference product to immediately begin work on possible patent infringement issues
May decide to forego the biosimilar pathway and instead pursue approval of a copycat biologic via a new biologic license application. This would not result in FDAapproval as a biosimilar, but the reduced or delayed risk of lawsuits may be worth it
Summary
Approval of the first U.S biosimilar medications may be around the corner. The previously existing abbreviated new drug application pathway is not suitable for biologics due to their size, complexity, and complicated manufacturing processes. The BCPI Act requires an applicant to disclose the application and its contents to the sponsor of the reference product within twenty days of filing the application[2] This will enable the sponsor of the reference product to immediately begin work on possible patent infringement issues. May decide to forego the biosimilar pathway and instead pursue approval of a copycat biologic via a new biologic license application. This would not result in FDAapproval as a biosimilar, but the reduced or delayed risk of lawsuits may be worth it. In the European Union (EU), where biosimilars have been on the market for years, several proposed biosimilars were withdrawn after clinical testing failed to demonstrate similar efficacy and safety to the reference product[6]
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