The U.S. FDA has approved the first therapeutically equivalent generics for Takeda’s Velcade® (bortezomib). Although Fresenius and Dr. Reddy’s have marketed generic bortezomib for several years, the U.S. FDA does not consider their products therapeutically equivalent because of differences in formulation.

• There are now eight approved bortezomib generics considered therapeutically equivalent by the FDA. They are available in the form of single-use vials containing 3.5mg bortezomib as a lyophilized cake or powder for reconstitution.
• Recommended dosing for bortezomib is 1.3mg/m² of the patient’s body surface area, given as either a 3-5 second bolus intravenous injection or a subcutaneous The dosing schedule and treatment duration depend on the indication and other patient-specific factors.
• The following manufacturers have launched their newly approved bortezomib generics: Apotex, Aurobindo, Baxter, Fresenius Kabi, Ingenus, Sagent, and Zydus.