A biosimilar is a replication of a biologic already on market (which is called 'the reference drug'). It cannot be a generic drug because biologics and biosimilars are made from living cells and grown in laboratories. Generic medicines, like an aspirin, are simple structures and can be replicated simply by a machine. The biosimilar has copied the active ingredient in the reference drug, but other non-active ingredients may differ in manufacturing.

In the United States, a biosimilar that earns the label "interchangeable" it means the biosimilar company has provided additional data to demonstrate that it a patient who is switched repeatedly between the reference product and the biosimilar can expect the same clinical result, without additional risks, relative to a patient who wasn’t switched. 

Sí. Estos medicamentos tuvieron que demostrar en ensayos clínicos que son tan seguros y eficaces como el biológico original. Al principio, AiArthritis y otras organizaciones de pacientes y médicos no estaban seguros de su seguridad, pero se han realizado muchos estudios en pacientes para asegurar que, al cambiar al biosimilar, el paciente no tendría una reacción ni perdería eficacia. Todavía existen algunas preocupaciones sobre el cambio en un paciente estable. Actualmente, los médicos aceptan más el cambio a un biológico si 1) el paciente no ha recibido tratamiento biológico previo, es decir, nunca ha usado ninguno, 2) el paciente está bastante controlado y es probable que no pierda eficacia al cambiar, y 3) es el momento de cambiar de biológico por completo. En Europa, la Agencia Europea de Medicamentos (EMA) declaró en 2022 que los biosimilares son "intercambiables" con el medicamento de marca. Esto significa que el medicamento de marca ("medicamento de referencia") "puede ser reemplazado por el biosimilar sin que el paciente experimente ningún cambio en el efecto clínico". Más información: A fecha de febrero de 2023, en Estados Unidos, la FDA no ha declarado que los biosimilares sean intercambiables.

First, don't panic. Biosimilars have been tested in clinical trials and have demonstrated they are safe and as effective as their originator, reference drug.   However, most physicians do not wish to switch a patient to a new medicine when they are doing well on their current therapy. But if the switch saves the patient or healthcare system money, it may happen.  

If a patient is not doing well on the original biologic, then they also will likely not do well on its biosimilar. So if you are not experiencing good outcomes from your biologic, you may want to talk to your doctor about switching to a new drug entirely.

Yes! In most countries, the use of biosimilars should lower costs to the healthcare system, which means more people with many conditions will have more access to the treatments they need. Patients may even see a discount. Savings has been demonstrated in Europe, but we will not know how much savings for patients - if any - will happen in the United States because of the healthcare system model and use of Pharmacy Benefit Managers (PBMs). 

We advise you to check the website of the manufacturer who makes your biosimilar for more information, as support programs may vary per country. These are common in the United States for patients who are not on government programs, like Medicare. 

Maybe. In European countries the use of biosimilars has made a difference in the funds available to the healthcare system (but it may not affect patients directly). In the United States, we have heard from some Medicare patients that biosimilars have helped them afford their medicines, as biologic/biosimilar manufacturer assistance plans are not available for those using this government program.