Although patients like Ms. Amisano are used to generic drugs, biosimilars won’t be as simple a switch, said Martin Zagari, MD, vice president of global health economics at Amgen, the biopharmaceutical company based in Thousand Oaks, Calif. Communication about biosimilars will help allay fears and confusion.
“We believe even more expertise will be required from such groups as the ACR. We should expect that most people are predicting that this notion of precision medicine and personalized medicine actually increases the role of deep expertise and patient-centeredness,” he said.
Room for Innovation
Savings generated by biosimilars will also open space in research and development budgets for future breakthrough products, said Dr. Zagari. “The medicines that are now seen as the most expensive are also going to be the ones that are creating new headroom for treatment. When these molecules are able to be provided in biosimilar form, they will have an effect on the system as profound as generic drugs have had to date.”
Focus on the improved, long-term health outcomes that more affordable biologic drugs can provide and the savings they will offer, he said.
“Predictability of innovation is actually becoming more and more something that we can count on as a society. How can we afford new medicines? In the 1980s and 1990s, only about one-third of medicines were generic. Now, it’s almost 90% of prescriptions. This is how we get [healthcare costs] under control,” he said.
The ACR leadership has done a tremendous job ensuring that biosimilars will work for clinicians and their patients, said Mr. Eich.
“The interest of society is having patients and physicians tell the industry, regulators, others: Here is how biosimilars can actually improve patient care, so patients can benefit and the practice of health care is improved,” he said.
Rheumatologists have been at the forefront in the use of targeted biologics and have deep experience to apply to ensure the safety and efficacy of biosimilars for their patients, said Dr. Daikh.
“It’s important that rheumatologists engage in this issue as biosimilars are being developed and as fundamental regulations regarding their production, testing and labeling are being promulgated,” he said.
Susan Bernstein is a freelance medical journalist based in Atlanta.
References
- Schellekens H. Biosimilar therapeutics: What do we need to consider? NDT Plus. 2009;2(Suppl 1):i27–i36.
- Gleason P. RA drug therapy projected to exceed $50k per person in 2022. Prime Therapeutics. 2013 May 23.
Terms to Know
Biosimilar: Biological therapy proved to be highly similar to an FDA-approved biological product, known as a reference product. Has no clinical, meaningful differences from the original drug in safety and effectiveness. Minor differences in clinically inactive components are acceptable.