Biologic facts

Brand

Actemra (Tocilizumab)

3 tocilizumab biosimilars from 3 makers are licensed, 1 of them interchangeable. The 12-year reference exclusivity date of 01/2022 is an estimate from first approval; the Purple Book does not list patents, which can protect a biologic longer.

Actemra was first approved by the FDA in 2010; the application holder is Genentech, Inc.

The latest NADAC for ACTEMRA ACTPEN 162 MG/0.9 ML is $1,279.06 per mL (as of 10/28/2026).

Holder Genentech, Inc.Approved 2010

01Exclusivity

When biosimilar competition can legally begin. The Purple Book lists reference exclusivity but not patents, which can protect a biologic longer.

Patents
Not listed in the Purple Book
Purple Book
Reference exclusivity
01/202212-year estimate from first approval
Purple Book

02Competition

Biosimilars
3 biosimilars from 3 makers
Purple Book
Interchangeable
1
Purple Book
Every makerEach licensed product and biosimilar maker.
PrescribersWho prescribes it, from Medicare data.
Spend and safetyMedicare Part B spend and safety reports.
Available in the full Actemra profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$1,279.06 per mLACTEMRA ACTPEN 162 MG/0.9 ML, as of 10/28/2026
CMS NADAC

04Product

Application holder
Genentech, Inc.
Purple Book
First approved
2010
Purple Book

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.