Biologic Response Modifiers for Subsequent Events
Follow-on biologics are generic biologics that are designed to mimic existing biologics. These, however, are complicated biologic molecules that need biotechnological synthesis using live tissue, as opposed to generic forms of synthetic DMARDs.
The FDA classifies follow-on biologics into two categories: biosimilars, which have the same mechanism of action as the original biologic (also known as a reference product) but no clinically significant differences in safety or efficacy, and interchangeable, which must meet the biosimilar standard and are expected to produce the same result in any given patient. In several states, pharmacists can swap interchangeably without the knowledge of the prescriber.
Although no biosimilars are currently approved for use in rheumatology in the United States, an infliximab biosimilar named Remsima has been used to treat RA in Europe. Celltrion Healthcare, the drug’s maker, is seeking FDA approval in the United States.
‘I’ll investigate the patient’s values, their fears about the disease, and what they’ve read about its therapy and risk tolerance.’ Then, finally, we establish therapeutic objectives.’ —Vivian Bykerk, Ph.D.
Hematologists use the launch of follow-on biologics and the approval of the first biosimilar in the United States, Sandoz’s filgrastim-and (Zarxio) for Amgen’s reference product filgrastim (Neupogen).
A recent randomized controlled trial comparing the Celltrion biosimilar to infliximab found equal efficacy, comparable side effects, and similar production of anti-drug antibodies. However, it only lasted 30 weeks.
6 A similar 24-week study comparing an etanercept biosimilar to reference etanercept found identical effectiveness, immunogenicity, and safety. 7
“Neither trial addresses the subject of immunogenicity in patients who switch from the reference medicine, which could occur in the case of interchangeable without the prescribing physician’s knowledge,” Dr. Goodman notes. In addition, the safeguards and requirements for physician and patient notice for interchangeability differ from state to state.
Be Wary of an Increased Risk of Heart Attack When Using NSAIDs
In July 2015, the FDA increased its warning about the effects of NSAIDs on the cardiovascular system. Rheumatologists should be aware of this.
8 They are more likely to have a heart attack following the first few weeks of therapy. The risk is also enhanced with greater NSAID doses and in people who do not have the underlying cardiac disease—though the risk is greatest in people who do have underlying cardiac disease. Therefore, the FDA advises patients and practitioners to be on the lookout for heart-related side effects.
‘When RA medicines are approved in the United States, the approval of biosimilars will add complication to rheumatology practice.’ —Susan M. Goodman, Ph.D.
Conclusion
When treating a newly diagnosed RA patient, consult the organization’s standard practices first. Then, assess each patient, outlining their unique needs and aspirations. Follow-up evaluations are required to establish the best course of treatment.