Allan Gibofsky, MD, attending rheumatologist and Co-director of the Clinic for Inflammatory Arthritis at Hospital for Special Surgery, in New York City, met with Rheumatology Advisor to discuss the recent introduction of biosimilar agents into the treatment armamentarium for rheumatic disease. This is part 1 of a 3 part video series on this topic.

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Transcript of Video

Hello, I’m Allan Gibofsky, attending rheumatologist at the Hospital for Special Surgery and Co-director of the Clinic for Inflammatory Arthritis here at Special Surgery. We are going to be discussing the very important and topical issue of biosimilars in autoimmune and rheumatic diseases. 

 I’d like to begin with a brief introduction to our topic of biosimilars.

A biosimilar is a biologic molecule that, as its name implies, is similar – but not identical – to the molecular after which it was made, which is called the bio-originator.

We are now seeing a number of molecules in the United States and elsewhere in the world that are biosimilars.  They are purported to have the same efficacy and safety as the bio-originator molecule, notwithstanding minor differences in their chemical composition.

Biosimilars in the United States were developed in response to a provision of President Barack Obama’s health care reform legislation in order to provide an avenue for less-expensive biologic medications for patients who need them.  In other words, the promise of biosimilars is going to be reduction in cost and increase in access.  

As to whether those promises are actually met remains to be seen, because we have yet to have a biologic biosimilar for any of the autoimmune diseases here in the United States market. Indeed, though biosimilars have been available in Europe and other parts of the world for several years, one cannot completely learn from their experiences because their payment and reimbursement systems are quite different.  

Yes, of course, you will see reductions in cost when there is only one person buying all of the drug in a country – namely the government – but in a country like ours, where there are multiple payors and multiple points of competition among drugs, it is unclear whether the introduction of biosimilars will reduce costs and improve access for our patients, or will solely reduce costs for the payors for the drugs – namely, the insurance companies.  It is a point that remains to be determined.

We have experience with one biosimilar in the United States market: a biosimilar to an oncology product, filgrastim.  There we have seen some inroads into the costs in terms of an increased market share of the biosimilar.  But as to whether we have seen increased access in the numbers of patients who need that drug remains to be determined, as well. 

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