Matias Matías, MD
CEMIC University, at Buenos Aires
TERMS TO KNOW
Biologics are drugs composed of living organisms or components of living organisms and may come from natural sources such as animals, humans, or microorganisms.
Biosimilars are drugs that are also made from living organisms, but they might be made differently or with different components compared to the biologic they are based on. To be classified as a biosimilar, the drug must show no significant differences in purity, potency, or safety from its biologic counterpart.
- In Argentina, an estimated 385,000 people are living with psoriasis.
- Access to biologics in Argentina is impacted by various factors, including — but not limited to — stability of the economy, geography and physical access, importation and regulation, and cost.
TIMELINE OF KEY ACHEIVEMENTS
2011: The Latin American Working Group forms as a part of the IPC to assemble regional experts to highlight local psoriasis issues on an international stage.
2015: Dermatology experts from Argentina, Brazil, Chile, Colombia, and Mexico meet and discuss the “definition, approval, marketing, and future of biosimilars” in their respective countries and develop a consensus statement.
2016-2022: Researchers across the globe study biosimilar access and availability in Latin American countries — aiming to overcome misinformation and distrust.
Raimondo N, Echeverría C, Stengel F, et al.. Biosimilars: Expert Consensus of the Latin American Society of Psoriasis (SOLAPSO) in Argentina. Medicina (B Aires). 2018;78(4):272-281. Spanish. PMID: 30125255.
de la Cruz C, de Carvalho AV, Dorantes GL, et al.. Biosimilars in Psoriasis: Clinical Practice and Regulatory Perspectives in Latin America. J Dermatol. 2017 Jan;44(1):3-12. doi: 10.1111/1346-8138.13512. Epub 2016 Jul 27. PMID: 27461455.
Biologics and biosimilars have created many new options in psoriasis treatment for patients worldwide, but patients worldwide face barriers to acquiring them. This has led IPC Councilor Dr. Matias Maskin to reconsider what success means for psoriasis patients.
“It’s not only the [physical] response we are looking for,” says Dr. Maskin, ”but the time that it takes us to get to that response — and the things that impact that progression in the first place.”
As a member of IPC’s Latin America Working Group, Dr. Maskin’s recent publications seek to explain the current state of biosimilars in Latin America, providing a range of perspectives. He speaks here about the perspective shift he’d like to see.
Barriers to biologics access in Argentina
One barrier to accessing biologics in Latin America is the instability of the economy and a patient’s ability to access psoriasis drugs consistently.
“Many factors impact whether you can access biologics at any time,” Dr. Maskin shares. “Not all biologics are available — many are not.”
For instance, drugs that might be available one year may face importation issues the year after. This instability results in patients and physicians navigating uncertainty in treatment from one prescription to the next.
“Let’s say you are a patient and you do have access,” says Dr. Maskin. “You are lucky, you are rich, and you have access to a dermatologist. Your dermatologist also has a specialty in psoriasis. Your doctor gives you the right drug. The system accepts to give you the drug. And then in 12 weeks, you just do not get the next dose. It is hard to plan for that as both a dermatologist and as a patient.”
In Argentina, an estimated 385,000 people are living with psoriasis. When considering social determinants of health, Dr. Maskin also emphasizes the impacts of geography on their access to care — and therefore on their ability to reach PASI 90.
“If you live in a village,” says Dr. Maskin, “You might never even get access to a dermatologist, let alone a psoriasis specialist. So many people do not have access to psoriasis treatment — not only because of the health system [and not] being able to buy drugs — but also [because] they don’t have the access to good clinical attention.”
The potential of biosimilars in Latin America
With significant barriers facing people in Argentina and Latin America, what does the future look like? Dr. Maskin believes that opportunities for more equitable access are on the horizon, particularly in the form of biosimilars.
The first biologic approved in Argentina — rituximab — was also made in Argentina. Rituximab was not originally a psoriasis drug, but rather a drug for pain or lymphomas. While its production in Argentina is meaningful, the difference in cost between the originator and the biosimilar was only 10% — resulting in a still-high price tag.
“There are two sides to the story of biosimilars — it has two faces,” Dr. Maskin says. “The good one is that if you have biosimilars, you have competition. You assume prices should go down. This isn’t always the case, but it is something you hope for. The other side of things is if you are getting ‘biosimilars’ in your country that are not actually biosimilars. These are not the drugs we want for our patients.”
With strong regulation — as there is in Argentina, Dr. Maskin explains — you may receive less variety of drugs than you would get otherwise, but you can have stronger confidence and ability to get the ones that are more effective.
Changing the way we think about psoriasis goals
As a global network of psoriasis experts and enthusiasts, it’s critical to look at the many different factors impacting someone’s psoriasis treatment and progress.
“The keyword is access,“ says Dr. Maskin. “We are always talking about what kind of goal we need for patients with psoriasis. We are always discussing if we need PASI 50, PASI 75, PASI 90 — but what we don’t know is the differences between undeveloped countries compared to developed countries in getting to PASI 90.”
It is not only about the physical journey patients go on with psoriasis — it is the many variables at play that can affect the speed of their improvement. Do they have access to biologics or biosimilars? Is that access consistent, or will they face months on end wondering when a specific drug will be available?
Do they have the funds, clinical expertise, and structural regulations in their country that better set them up for a certain definition of success? Or do we need to reconsider what “success” really looks like?
“We don’t only need to ask, ‘How long does it take someone to get to PASI 90?’ We need to also be asking, ‘How long does it take a patient to get access to that drug?’” Dr. Maskin says.