Sandoz’s Zarxio became the first biosimilar to be launched in the US earlier this month, but despite this milestone, questions around the interchangeability and impact of such compounds remain unanswered.
And so when Alex Gorsky - CEO of J&J whose Janssen unit manufactures several proprietary products being targeted by biosimilar developers - presented at the Wells Fargo 10th Annual Healthcare Conference last week, he was asked his views, perhaps unsurprisingly, on the effect of copycat biologics.
“We believe that biosimilars and generics are very different, but both play a very important role in the healthcare ecosystem,” he said. “If it weren't for generic drugs, if it weren't for biosimilars to a certain degree, there would be no way that we could sustain an innovation-based healthcare system, because you wouldn't have any pressure relief in the system.”
He confirmed “biosimilars (and generics) are, in the long run, good for innovation,” but added the caveat that it is essential to fully understand the biological differences between the compounds.
“We know from our own experience with Procrit (epoetin alfa) a number of years ago, that a very minute change in a component of one of the packaging material can end up having an impact on protein itself and on the way that it manifests itself clinically in terms of immunogenicity and side effects.
“And so to think that a biosimilar is going to have the exact same clinical effectiveness, the same side effect profile, just isn't the case.”
Therefore, he continued, not to assume “the level of interchangeability, the level of substitution that you see with biosimilars is going to be anywhere near what you see with the generic drug, particularly with patients who are already getting good treatment on therapy.”
Competition
Janssen’s monoclonal antibody Remicade (infliximab) is beginning to feel the pressure from copycat competition. Hospira has launched its version, Inflectra, across a number of European countries, while Celltrion’s Remsima is under review in the US.
But Gorsky remained unfazed, saying that not only was it unlikely that patients currently on Remicade (approximately two million) will be actively switched, but that the biosimilar sector will not involve as many players or have the dramatic price reductions seen in the generics sector.
“The biosimilar business model, given the capital investment required, given the investment in clinical trials is very different than in generic business model,” he said, and “the price that you actually charge, relative to some of the discounts that are already being provided in the branded biologics market, is another dynamic that I don't think people fully understand.”
He placed the reductions at around 25-30% less than the proprietary drug. Zarxio’s wholesale cost, however, was just 15% lower than Amgen’s Neupogen.
And so while biosimilars will “have an impact over time,” he concluded that it won't be anything like a generic erosion pattern and has “broadly been overemphasized relative to the threat to the business.”