Recently the Business of Biosimilars and Generic Drugs team sat down with Mark McCamish, the Global Head of Biopharmaceutical Development, Sandoz International, a Division of Novartis to discuss the current state of biosimilars and many of the regulations,or lack there of, facing the United States. Today's question: What are the best techniques and media for reassuring both patients and physicians about the quality of biosimilars? Is there anything in particular from a purely messaging and outreach perspective that you believe the biosimilars community could learn from techniques previously established for small molecule generics?
Mark's Answer:
I think communication is really key. Martina Weise from the European Medicines Agency (she’s on the Biosimilars Working Party for EMA) had communicated just about two weeks ago in an international conference in London that misinformation is the biggest problem that they’ve had in moving biosimilars forward in Europe. So, the misinformation is something that we have to address proactively. We have to get out in front of this in terms of the education of individuals (not only physicians but payers, as well as patients) regarding the benefit of biosimilars.
Educating about biologics is critical from the first place since there is limited understanding that biologics do change over time due to changes in manufacturing. The manufacturing process is altered or changed to scale up the process or transfer it to a different manufacturing plant. There are some inherent changes in the glycosylations of the molecules on the originator. So, the original biologic molecule does vary over time and it is not identical to itself over time. In light of this, one of the pieces of misinformation is that biosimilars are not safe or they are not efficacious because they are not identical to the originator molecule. Well, the fact is that the originator molecule is not identical to itself due to the complexities of biologic manufacturing. Sandoz uses the variability of the originator molecule over the years to provide a target for us to select the product attributes of the originator molecule. We try to design our biosimilar to be as close to the originator as the originator is to itself. It is important to communicate that the biosimilar name is a regulatory term that communicates the product has the same efficacy and safety profile
So, from a communication perspective I think we just have to start at the basics and talk about the overlapping with the originator molecule and when they are approved, they are approved to have the same safety, the same efficacy as the originator molecule. In fact, the European Commission has stated previously that if they approve a biosimilar, it is as safe and as effective as any other medication that they have approved. These are the types of educational processes that we’ll have to implement.
For access to the entire podcast and transcript, download it here.
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