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Follow-on Biologic Response Modifiers

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 exact 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-sndz (Zarxio), for Amgen’s reference product filgrastim (Neupogen). “When RA medicines are approved in the United States, the approval of biosimilars will add complication to rheumatology practice,” Dr. Goodman adds. “The advantage of follow-on biologics is that they are less expensive than existing biologics and, as a result, will be more accessible to RA patients.”

 

Because biologics are enormous, complex molecules produced utilizing cell lines in a tightly regulated environment, there is fear that minor modifications could result in an immune response to the medicine, resulting in decreased efficacy. This issue will need to be addressed in extensive, long-term clinical trials, according to Dr. Goodman.

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. A similar 24-week study comparing an etanercept biosimilar to a reference etanercept found identical effectiveness, immunogenicity, and safety.