Biosimilars Reviewed by Expert Panel Save

As the number of biosimilars in development keeps on growing, reaching nearly 700 products to date, demand for data from randomized controlled trials (RCTs) and an understanding of these new biologics  is peaking the interest of many. 

Dr. Thomas Dorner and a panel of international experts convened in Frankfurt in August 2015 to summarize existing data and provide an update on the status of biosimilars for treatment of rheumatic diseases.

Biosimilars offer cost savings and health gains for many patients and will play an important role in treating rheumatic diseases in the future. This review article covered many of the evolving issues surrounding biosimilars and helps to answer burning questions about use, indications, switching form reference products, pricing, etc.

Some of the issues covered by this review article include:

• Regulatory issues: At the time of their conference, 30 applications for biosimilar products had been evaluated in the EU and 22 biosimilars approved in Europe across six classes. The FDA has approved 2 biosimilars to date and Janet Woodcock has said they have 59 proposed biosimilars for 18 different reference products up for consideration by the FDA.
• Clinical trial design: To gain regulatory approval for a biosimilar, EMA and FDA require a pharmacokinetic/pharmacodynamic study in humans and at least one RCT to demonstrate equivalent efficacy and immunogenicity and comparable safety of the biosimilar to its reference product. 
• Switching: There is limited data on the safety and efficacy of switching or transitioning to a biosimilar from the reference product. To date, this has only occurred in one randomized switch from the reference product to the biosimilar (without incident) in the PLANTEAS study comparing CT-P13 to infliximab.
• Extrapolation: Once a biosimilar has been shown to be “highly similar” then it potentially gains the same clinical indications even though the comparison clinical trial may have only been done in one disorder (e.g., rheumatoid arthritis).  For instance, all mAb-based TNF inhibitors, despite differences in their molecular characteristics, have efficacy across the same indications; therefore, a molecularly correctly developed biosimilar mAb is expected and one trial may result in multiple indications.
• Budget savings: The impact of switching patients to CT-P13 for RA in the UK, Italy, France and Germany is estimated over 5 years yield savings of €233 million and €433.5 million with 20% to 30% discounts in effect. 

This expert group summarized their recommendations for future use of biosimilars as follows:

• Pay close attention to which biosimilar product is being prescribed and used.
• ·Prescribe using the proper name or trade name with suffix.
• ·Contribute to local and international pharmacovigilance efforts (registries).
• ·Conduct quality pharmacovigilance to monitor long-term safety, with harmonization of data collection across registries.
• ·Encourage transparency in drug characterization.