Posted from: Tuesday, September 27, 2016 - 02:03 PM - Present

Biosimilar to Enbrel Approved

August 30, 2016 – The FDA approved Erelzi (etanercept-szzs) for the treatment for multiple inflammatory diseases.   Erelzi, manufactured by Sandoz, is a biosimilar to Enbrel, which is manufactured by Amgen.  Erelzi and Enbral are not interchangeable products.

Erelzi is administered by injection for the treatment of:

Dosing may vary for each approved use and product labeling should be carefully reviewed.  Erelzi contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, invasive fungal infections (such as histoplasmosis) and others.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Monday, September 18, 2017 - 08:17 AM.