What the ACR says about biosimilars

Medicines

15 Mar 2015

Rigorous research,  safeguards against repeated switching and a need for distinctive naming and post-marketing surveillance are among the main concerns highlighted in the American College of Rheumatology’s position statement on biosimilars.

“We agree that less expensive biologic therapies are needed and recognize that biosimilars provide an opportunity to reduce treatment costs; however close monitoring of possible differences in the safety and efficacy of biosimilars and interchangeable biologics is needed as they enter the market,” said ACR President E. William St.Clair.

Related news: Biosimilars are coming soon – are you ready?

In its position statement the ACR highlights the need for:

Rigorous clinical trials to ensure the safety, efficacy and interchangeability of biosimilar drugs with original biologic drugs.

Safeguards against repeated switching among biosimilars.

Policies that only allow physicians to prescribe and authorise substitution of a  biosimilar.

Distinctive names for biosimilar drugs compared to original biologics.

Long‐term post‐marketing surveillance and adverse event tracking.

 

Already a member?

Login to keep reading.

OR
Email me a login link