All posts related to "biosimilar"

Let BC PharmaCare hear “Your Voice” on etanercept SEB

Stick man holding megaphoneBC PharmaCare is looking for your input on etanercept SEB for the treatment of rheumatoid arthritis and ankylosing spondylitis

Etanercept SEB is a subsequent entry biologic version of etanercept (Enbrel). Etanercept SEB is used for treating people with moderate to severe rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and works by targeting the tumor necrosis factor alpha (TNFA) molecule. It is given by subcutaneous injection.

A SEB needs to have the same mechanism of action as the originator biologic it was compared to, which means it should work in a similar way. Health Canada defines SEBs as a “biologic drug that enters the market subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug.” Continue reading

FDA proposed new naming policies for biosimilar drugs for RA

Yellow and Purple pills in palm of handThe Food and Drug Administration (FDA) has proposed new naming policies for the distinct naming of biosimilars and biologics for rheumatoid arthritis treatment. The new draft guidance is called Nonproprietary Naming of Biological Products: Guidance for Industry and is available to view here.

Under the new policies, which will be designated and enforced by the FDA, separate and distinctive names will be required when it comes to biosimilars and biologic drugs. This will ensure that pharmaceutical companies are following regulations and will remain compliant when it comes to the naming and marketing of biosimilar medications.  Continue reading