Amgen says using the same development expertise and manufacturing capabilities for both its biosimilar and novel biologic programs sets it apart in the industry.
Pharma firm Amgen is one of a handful of firms that has successfully invested in both innovator products and biosimilars – biologics that are very similar to reference biologics and for which there are no clinically meaningful differences in terms of safety, purity, and potency.
With expected 2021 biosimilar revenues set to reach $2 billion, CEO Robert Bradway told delegates at the Goldman Sachs 14th Annual Healthcare last week that his firm was able to report “earning returns here for our shareholders that are well above our cost of capital” by capitalizing on four decades of experience in designing, manufacturing, and marketing innovative large molecules.
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“The fundamentals of manufacturing biosimilars aren’t simple, right? The process of designing them to actually be biosimilar aren’t simple, and that’s why you’ve seen many competitors stumble either in their timelines or even actually getting molecules approved. And then you’ve seen competitors stumble and not be able to supply biosimilars once they’ve been approved,” he said.
While he did not name names, examples include Momenta Pharmaceuticals exiting the biosimilar space in 2019 following a lengthy strategic review and Merck KGaA divesting its biosimilar business in 2017. Meanwhile, some rival big biosimilar players have pulled development programs, including Boehringer Ingelheim, Novartis division Sandoz, and even Pfizer, which abandoned five preclinical programs in 2019.
Bradway said getting biosimilars registered in a timely way is a major hurdle but one that Amgen has successfully done by establishing biosimilarity and making them safely and reliable in large quantities.
Specifically, he said the firm is manufacturing “an awful lot” of Amgevita, the firm’s version of Humira (adalimumab) – which pulled in nearly $20 billion for AbbVie in 2020 – and Mvasi, Amgen’s version of Roche’s Avastin (bevacizumab).
“We’re doing it successfully, safely and we’re using the same facilities for that purpose that we use for our innovative medicines,” he said. “We’re not treating it as a separate business, a stepchild that’s not getting the same kind of attention from a process development or quality or manufacturing rigor that are innovative products again.”
Bradway added a second hurdle for biosimilar makers is making them available for the payors and those seeking to procure them. Biosimilars have, in the US at least, been slow to market and played second fiddle to innovator biologics in the eyes of the buyers. However, Amgen is leveraging the same sales teams that is “out there advocating for innovative products to be able to offer the biosimilar products to their customer base,” which according to Bradway is a major advantage.
“We can go into customers and say, here are the innovative proprietary Amgen oncology drugs that we want to talk to you about and here are the biosimilars that we can provide to you as well. And so far, that has worked well for us.”