More than thirty patients with rheumatoid arthritis have experienced early relapses and a lack of clinical response after receiving the biosimilar drug Rixathon in Panama’s Social Security Fund hospitals. The Rheumatoid Arthritis Foundation of Panama raised the alarm this week, stating that medical reports detailing these therapeutic failures have been formally submitted to the institution’s pharmacovigilance system.
The concerns originate from documentation compiled by the Rheumatology Service at the Dr. Arnulfo Arias Madrid Hospital Complex. Specialists there recorded cases of therapeutic inefficacy as early as the fourth month after administration. This timing is notably premature, as standard clinical protocols for this type of medication anticipate response intervals of six to eight months.
“When a patient is stable, changing their treatment solely for economic reasons can generate relapses, complications, and higher costs for the system,” said Luris Higuera, President of the Advocacy Commission for the Rheumatoid Arthritis Foundation of Panama (Funarp). [Translated from Spanish]
Patients describe a return of debilitating symptoms. They report persistent pain, progression of joint damage, and the need for additional infusions without achieving sustained improvement. Beyond the lack of effectiveness, the filed reports also note adverse reactions that were not previously observed with the original biologic drug. Treating physicians have formally notified these cases and recommended switching patients to alternatives with a proven safety record and current sanitary registration in Panama.
Public Tender Prioritizes Price Over Patient Reports
These clinical warnings, however, were not considered in a recent public procurement process conducted by the Social Security Fund. The controversy centers on Public Tender LPU No. 05-2026, specifically lines 41 and 42 designated for acquiring high-cost biotechnological drugs. According to Higuera, the determining evaluation criterion was the lowest price offer. The documented pharmacovigilance reports and the clinical experience of specialists were not factored into the decision.
Funarp argues this practice contravenes current legal provisions. They cite Law 419 of February 1, 2024, and Executive Decree No. 27 of May 10, 2024, which mandate the oversight and guarantee of safety for biotechnological medicines. Another decree, Executive Decree No. 882 from December 2021, prohibits the substitution of biological drugs without the express authorization of the prescribing physician. The foundation insists the tender award decision ignored critical factors like real-world clinical effectiveness, treatment continuity, and the impact of adverse events on patient quality of life.
Higuera acknowledged that no medicine is perfect. She stressed, however, that more responsible decisions must stem from clinical experience and patient welfare. The situation has sparked a wider technical debate about the standards governing the introduction of biosimilar drugs into the Panamanian market.
Experts Call for Rigorous Standards and Vigilance
Ivonne Torres Atencio, Director of the Department of Pharmacology at the University of Panama, clarified the international standards for biosimilar approval. She explained that such medications must first be approved by high-level regulatory agencies like the European Medicines Agency or the U.S. Food and Drug Administration. All medicines, without exception, must demonstrate both efficacy and safety.
“All medications must comply with efficacy and safety standards. What is important is that there is correct traceability and pharmacovigilance for each batch,” stated Ivonne Torres Atencio. [Translated from Spanish]
Torres Atencio emphasized that for biotechnological drugs, guaranteeing adequate batch traceability and a robust pharmacovigilance system is fundamental. She pointed out that Rixathon’s active ingredient is a chimeric monoclonal antibody which requires premedication to reduce the molecule’s own immunogenicity. This fact demands even stricter clinical vigilance. The specialist called for a critical analysis of the failure reports, contrasting them with real-world experience from countries like Spain where these biosimilars are widely used.
She also highlighted factors beyond the drug itself that can affect clinical outcomes. Careful monitoring of the cold chain, storage, and distribution of the product is crucial. Any deviation in these logistical elements can directly impact the drug’s effectiveness for treating conditions like rheumatoid arthritis. Furthermore, any adverse event must be promptly notified to the producing laboratory to contribute to global safety data.
The allegations have placed a spotlight on the Dr. Arnulfo Arias Madrid Hospital Complex, a key facility within Panama’s public health infrastructure. The hospital’s own specialists are the source of the concerning reports, creating an internal conflict between clinical observations and procurement decisions. This is not the first time the complex has been involved in institutional controversies, though the current issue revolves squarely on patient safety protocols.
Patient advocates now await an official response from the Social Security Fund regarding the tender award and the steps that will be taken to address the reported therapeutic failures. The foundation insists that patient safety and proven clinical outcomes, not just cost savings, must be the paramount concern in public health procurement.