ACR Releases New Position Statement on Biosimilars: Encourages Strict Oversight, Scientific Study & Physician Involvement March 12, 2015 ATLANTA — The American College of Rheumatology (ACR) has released a new position statement on the medical use of biosimilar drugs in patients with rheumatic disease. The announcement comes shortly after the FDA’s approval of Zarxio (filigrastim-sndz) for sale in the United States. “As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high cost and patients being unable to afford them,” said ACR President E. William St. Clair, MD, FACR. “We agree that less expensive biologic therapies are needed and recognize that biosimilars provide an opportunity to reduce treatment costs; however close monitoring of possible differences in the safety and efficacy of biosimilars and interchangeable biologics is needed as they enter the market. It is uncertain whether patients will respond to these drugs the same way they would to an original biologic, because biologics are very sensitive to manufacturing changes. Even minor differences in a biosimilar’s molecular structure, purity or other chemical properties could change the way a patient responds to the drug.” Issues/concerns addressed in the ACR’s position statement include: The need for rigorous clinical trials to ensure the safety, efficacy and interchangeability of biosimilar drugs with or iginal biologic drugs. The statement explains that biosimilar manufacturers reverse engineer original biologics to develop a biosimilar alternative, creating a “tremendous degree of complexity in determining whether or not a biosimilar is similar enough to the original biologic that physicians and patients can be confident in using the new therapeutic.” The need for safeguards against repeated switching among biosimilars. Experience with biosimilars outside the US has raised concerns over the possibility of adverse reactions in patients. The ACR believes there are too many unknowns about biosimilars to presume that repeated switching will be a safe practice. The need for policies that only allow physicians to prescribe a biosimilar. The ACR believes physicians should have the right to designate a prescription as brand only to prevent substitution whenever appropriate (e.g., when concerned about patient safety). These policies should include safeguards that prevent payers from forcing patients who are responding adequately to their current biologic therapy from switching to a biosimilar. If legislation permits a pharmacist to substitute a biosimilar, the ACR recommends prior notification to both the physician and patient to ensure that the patient can be properly monitored for the development of any adverse effects and that the patient’s medical records can be updated accordingly. The need for distinctive names for biosimilar drugs compared to original biologics. The ACR feels distinctive names allow for transparency in notification/substitution and make it clear to all parties involved which drug the patient is receiving. Non-distinguishable names may cause confusion and lead to prescribing biosimilars for non-approved conditions. The need for long-term post-marketing surveillance and adverse event tracking. The position statement includes information on why “the complexity of the drugs requires individual monitoring of each biosimilar.” This complexity reaffirms the ne ed for distinctive names, so both the patient and physician can report any adverse reactions specific to the biosimilar in question. This important reporting and cataloging of adverse events would be difficult, if not impossible, without distinctive names for each biosimilar. The ACR’s Government Affairs division addressed these issues/concerns in a joint letter with the Arthritis Foundation to the FDA Oncologic Drugs Advisory Committee prior to their Jan. 7, 2015 meeting to discuss Zarxio and continues to actively follow issues, policies and legislation at both the federal and state level surrounding biosimilars. A member of the ACR will also speak before the FDA Arthritis Advisory Committee that will consider an application for a biosimilar for Remicade® (infliximab). The biosimilar is designed for the treatment of rheumatoid arthritis, Crohn's disease and plaque psoriasis. “We will continue to follow the various issues surrounding the distribution, monitoring and reimbursement of biosimilars very closely as state and federal poli cies are proposed that affect our patients and the rheumatologists who serve them,” said St.Clair. “Ensuring patients have easy access to affordable treatment options and rheumatology care continues to be a high priority for us.” The position statement was approved by the ACR Board of Directors in February 2015 and made available on the ACR website this week. Media Contact: Jocelyn Givens404-633‐3777, ext. firstname.lastname@example.org ###The American College of Rheumatology is an international medical society representing over 9,400 rheumatologists and rheumatology health professionals with a mission to Advance Rheumatology! In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit www.rheumatology.org.