How FDA's PK Guidance Shapes Teva's Next Biosimilar Program

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In March 2026, the FDA issued draft guidance to streamline the pharmacokinetic (PK) testing required in biosimilar development, including allowing PK studies to use a comparator product approved outside the US when scientifically justified, a change that FDA Commissioner Marty Makary, MD, MPH, said could cut PK study costs by up to 50%.¹

The guidance arrives as Teva Pharmaceutical Industries completes its pair of denosumab-adet biosimilars (Degevma, Ponlimsi), referencing Xgeva and Prolia (Amgen), respectively. Teva announced the FDA approval of Degevma, its Xgeva biosimilar, on September 28, 2026, about 6 months after the approval of Ponlimsi, its Prolia biosimilar. The Degevma approval covers all of Xgeva's indications and was based on a totality of evidence, including analytical and clinical data demonstrating efficacy, safety, and immunogenicity similar to the reference product.²

"We completely support the US FDA's view of relaxing the regulatory framework for biosimilars," Robert Cook, PhD, head of generics R&D and senior vice president of global technical development at Teva, said in an interview with The Center for Biosimilars. "We do think it will catalyze the uptake or adoption of biosimilars across the market and reduce health care costs as a result."

Cook said the efficacy data at the primary and secondary end points were likely the most compelling part of Teva's denosumab clinical program.

"But if you take that data together with all of the other clinical efficacy studies that other companies have run across the biosimilar industry, it's not offering a lot of incremental benefit over all of the analytical characterization of work that goes on," he explained.

Industry and regulatory working groups have pushed to move away from clinical efficacy studies and toward analytical characterization, Cook said, a shift that puts industry and regulators "in a good place" and provides better access to medications at affordable prices.

For Teva, that means future programs will pair analytical characterization with PK studies that confirm equivalent blood levels and exposure and test for markers of immunogenicity. It isn't a full clinical efficacy study, Cook said, but it is "a considerable clinical safety package."

"What does it mean for our next biosimilar program?" Cook said. "You have really strong characterization and analytical characterization using state-of-the-art equipment across a lot of expertise…Between the analytical characterization and that PK—that's how we'd approach the next biosimilar."

References

1. Al-Faruque F. FDA proposes major change to biosimilar PK study requirements. Regulatory Affairs Professionals Society. March 2026. Accessed October 8, 2026. https://www.raps.org/news-and-articles/news-articles/2026/3/fda-proposes-major-change-to-biosimilar-pk-study-r

2. McCrear S. Teva completes denosumab biosimilar pair with FDA nod for Degevma. CFB. September 29, 2026. Accessed October 8, 2026. https://www.centerforbiosimilars.com/view/teva-completes-denosumab-biosimilar-pair-with-fda-nod-for-degevma