Novartis’ Sandoz is looking to biosimilars to help it out of an industry-wide generics slump. And to spur greater uptake of those drugs, it has new data supporting switching patients from branded products.
Friday, the knockoffs giant rolled out results from two long-term phase 3 studies, one each looking at rheumatoid arthritis products Zessly—its version of Johnson & Johnson’s Remicade, sold by Merck Europe—and Erelzi, its copy of Amgen’s Enbrel. Each showed the Sandoz biosim could match its reference product in terms of safety and efficacy, and that moving onto the copy from the reference product had no negative effects.
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Novartis is hoping the new data will ease any concerns around use of the less-expensive copies and prompt doctors to transition their patients. "It is our hope that these studies will help healthcare providers and patients have confidence that switching to Zessly or Erelzi will continue to deliver the benefits they are receiving from their existing treatment,” Merck Levick, Sandoz’s global head of biopharma development, said in a statement.
Novartis is counting on biosimilars to come through at a time when generics pricing pressure has put the squeeze on Sandoz and other manufacturers. In the first quarter, Sandoz sales shrank by 4% in constant currencies, hurt by 6% price erosion that the company mainly had the U.S. to thank.
On the flip side, Erelzi sales in Europe helped drive Sandoz’s global biopharmaceuticals haul up by 13%, after a May approval from European regulators, Zessly can now chip in, too.
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In the U.S., though, biosimilar approvals and launches have been slower. Erelzi, after winning an FDA nod in August of 2016, faced delays on account of a legal battle between Novartis and Enbrel-maker Amgen. And as Pfizer—maker of another Remicade biosim, Inflectra—can attest, biosimilar uptake in the U.S. has been slower, too.
Still, Novartis—which won the first-ever U.S. biosimilar approval with its green light for Zarxio, a version of Amgen’s Neupogen—has more biosimilars on the way that it thinks can set it up for success down the line. The FDA has already accepted its applications for megasellers Rituxan from Roche and Humira from AbbVie, and the company is planning to refile an application for its Neulasta biosimilar next year after addressing a Complete Response Letter from the FDA.