GAfPA Blog

The GAfPA Patient Advocacy Blog

GAfPA “NOR-SWITCH” Paper Explores Impact of Biosimilar Switching Research

Data from a clinical study in Norway may soon explain the effects of switching stable patients from a biologic medicine, infliximab, to its biosimilar counterpart. But, as the Global Alliance for Patient Access argues in a new white paper, policymakers must accurately interpret what the NOR-SWITCH study will – and will not – demonstrate about the … Continued

NOMBRANDO MEDICAMENTOS BIOSIMILARES: América Latina y más allá

En 2015, la Organización Mundial de la Salud (OMS) anunció su propuesta de denominación de medicamentos biosimilares que son similares, pero no idénticos para referenciar a los medicamentos biológicos. La propuesta de la OMS sugiere que los biológicos de referencia y biosimilares tienen un nombre/ denominación común internacional (INN) que los cualifica usando al azar … Continued

Global Poster Presentations Convey Need for Distinct Biosimilar Names

Patient advocates have teamed up to take an important message to European physicians and policymakers: distinct names for biosimilar medications are essential. The Global Alliance for Patient Access and the Alliance for Safe Biologic Medicines recently presented posters at two European health policy meetings. The posters feature survey data from physicians to highlight the need … Continued

NORSWITCH Meeting Invites Dialogue on Biosimilar Switching

As more biosimilars become available globally, clinicians are eager to understand: How does switching between biological medicines affect patients? On June 13, the Global Alliance for Patient Access hosted an international group of physicians, researchers and patient advocates in London to take a closer look at one source of clinical data on switching – the … Continued

World Health Organization Finalizes Distinct Naming Scheme for Biological Medicines

After years of international debate, the World Health Organization has issued its final proposal embracing distinct names for biological medicines, including biosimilars. The organization opts for four-letter biological qualifiers to follow biological medicines’ international nonproprietary name.   The approach acknowledges patient and advocates’ concerns that distinct names be applied to ensure clarity, patient safety and the … Continued

Australian Regulators Recommend Biosimilar Substitution without Notification

Australian pharmacists could soon substitute a biosimilar infliximab for its reference product without prescribing physicians’ –or even patients’—knowledge. The Department of Health’s Pharmaceutical Benefits Advisory Committee has recommended adding an infliximab biosimilar to the country’s list of approved drugs as an equivalent to its reference product. Known as “a-flagging,” the move would allow pharmacists to … Continued

GAfPA Encourages Standards-based Guidelines for Colombia’s Biosimilars

Colombian regulators’ ill-defined “alternative approach” to approving biosimilar medicines has the country’s patients unsettled. In a recent letter to the Ministry of Health and Social Protection, several Colombian patient organizations joined with the Global Alliance for Patient Access in emphasizing biological medicines’ complexity and the impact of immunogenic responses. Approving biosimilar medicines through anything other … Continued