From The Editor | August 28, 2018

Brazil's Ministry Of Health Weighs Biosimilar Safety, Interchangeability

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By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

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From a young age, my career aspirations were a delightful blend of the practical and fantastical. My first career goal was to be a veterinarian. That was, until teenage Anna Rose discovered Lara Croft in the video game Tomb Raider and thought that could be pretty cool (minus the dangerous thugs). Clearly, neither of those career paths panned out. However, being editor of Biosimilar Development never fails to keep me my toes — especially when it comes to travel. Not only did I learn about the life sciences industry in Thailand last year, but earlier this month, I also found myself in Brazil speaking at an event held by The Ministry of Health and Grupo FarmaBrasil, which represents the national research pharmaceutical industry.

Brazil has spent the last decade working on its Productive Development Partnership (PDP) program to bolster local manufacturing of biosimilars. But due to a number of market challenges, which I highlighted in my previous article on Brazil, the government is still carving out the country’s biosimilar policies. The hope was that this event would serve as a forum for discussion about biosimilar experiences around the world and lay out steps for the Brazilian Ministry of Health to consider as it establishes its own policies.

During the two days, I was privy not only to presentations and words of wisdom from fellow speakers Adrian van den Hoven (Medicines for EU), Nikolai Brun (Danish Medicines Agency), and Hellen Silveira (Rheumatologist), but also to the questions and goals of the Ministry of Health. It’s going to be a long road ahead, but the attendance at this event and the level of engagement was remarkable. Though the extent to which biosimilars will be used in the country is still unclear, I’m hopeful based on this meeting that the upcoming policies will provide a successful path forward for the country.

Safety, Efficacy, And Interchangeability Earn Special Emphasis

During my presentation at the event, I shared as much information as I could about biosimilars’ safety and efficacy, as well as the educational initiatives I feel have been particularly effective. I also included several initiatives that are dedicated to studying real-world evidence, for instance the U.K.’s National Health Service’s (NHS’) BioValue program and the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC). My end goal was to provide inspiration for companies and the Ministry of Health when creating education initiatives. But even more importantly, it was to ensure that hypothetical concerns about safety and efficacy do not keep the government from purchasing biosimilars for the publicly funded healthcare system, the Sistema Único de Saúde (SUS).

As we’ve witnessed in a number of countries, there are, naturally, concerns from patient organizations and physicians once the government begins purchasing and encouraging switching to biosimilars. There’s no way to avoid these concerns. However, I was happy to hear Silveira’s presentation, given her role as a practicing rheumatologist with biosimilar experience. In addition to discussing her support of biosimilars, she was also cognizant of a fact which is often missing from innovator education strategies and physician knowledge — that all biologics differ from batch to batch. Indeed, she ended her presentation with an image of two twin girls looking at two Van Gogh paintings of sunflowers. Not only are the twins “biosimilars,” but the sunflower paintings are almost identical. There are a few minor differences between the two paintings, but it’s perfectly clear it’s the same flower arrangement.

Outside of the basic questions about safety and efficacy, the country is also engaged in a large debate about interchangeability. The Brazilian health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA), currently approaches interchangeability the same way as the European Medicines Agency (EMA). Unlike the U.S., which links interchangeability to substitution at the pharmacy level, interchangeability in Brazil is a medical practice under the purview of the physicians, patients, and Ministry of Health. As such, ANVISA has not published any guidance documents specifying additional data or studies required to evaluate interchangeability of a biosimilar with its reference product. The agency has only specified that patients should not be switched multiple times between the biosimilar and comparator product for traceability reasons.

However, similar to what we’ve seen in the U.S., Brazilian physician communities are pushing for an official interchangeability policy. As one publication from March 2018 shares, there has been a large push to regulate interchangeability because of physicians’ discomfort with biosimilars’ abbreviated clinical data packages. These demands have become front and center following a public hearing in August 2017, at which the government expressed interest in interchangeability and automatic substitution to ensure greater biosimilar access, savings, and national health benefits.

Indeed, during our discussion in a closed meeting with the Ministry of Health, it became clear that officials are seriously considering how to establish interchangeability guidelines. Should the Ministry of Health choose to purchase the biosimilar at high volumes for the SUS, this means patients will be transitioned at a large scale from the biologic to the biosimilar. In addition, there is a large, privately insured population in Brazil, and drug stores are responsible for filling those prescriptions. As such, this raises questions about the need for automatic substitution policies at the pharmacy level for self-administered biosimilars.

In the next article unpacking this meeting, I will be discussing the questions the Ministry of Health posed towards Brun in particular about Denmark’s experience with interchangeability and post-marketing surveillance. I’ll also be addressing some of the challenges facing the country in the realms of procurement and supply-chain security. Stay tuned!