Inside Teva's Denosumab Biosimilar Strategy: Robert Cook, PhD

With the FDA approval of Degevma (denosumab-adet), a biosimilar to Xgeva, Teva now holds a denosumab biosimilar pair covering the reference products’ indications, alongside Ponlimsi (denosumab-adet), its Prolia biosimilar approved in March 2026.¹

In an interview with The Center for Biosimilars^® (CFB), Robert Cook, PhD, head of generics R&D and senior vice president of global technical development at Teva, discussed the clinical program behind the approvals, the company's 2-application regulatory strategy, interchangeability, in-house manufacturing, and how manufacturers can differentiate in a crowded denosumab market.

Robert Cook, PhD, of Teva discusses the clinical program and regulatory strategy behind the company's denosumab biosimilar pair. | Image credit: @LinkedIn

This transcript was lightly edited for clarity.

CFB: The press release cites a "totality of evidence" but doesn't describe the clinical program. What study population and end points did Teva use? If the trial was run in a single population, like postmenopausal osteoporosis, how did Teva support extrapolating to oncology indications such as giant cell tumor of bone and hypercalcemia of malignancy?

Cook: The study was conducted in 300 [332 randomized] postmenopausal women with osteoporosis who had a confirmed diagnosis. The primary end point was the percent change in bone mineral density at week 52. Fast forward to the end of the study: The primary end point was met, as were a number of secondary end points at different time points—say, 26 weeks—and different biomarkers also met the secondary end points. So that was the study, which was designed to confirm the clinical efficacy of the denosumab biosimilar.

When it comes to the extrapolation into the oncology indications, at the time, the FDA expected you to run 1 confirmatory study in a sensitive population. In this case, we chose osteoporosis and then supplemented that with a very strong comprehensive analytical characterization package, and that provides the totality of evidence. The FDA doesn't expect you to run clinical efficacy studies in each and every indication, so they took that data from the osteoporosis study, combined it with all of the other data that we submitted, and approved a denosumab product across all indications.

CFB: Degevma and Ponlimsi share 1 nonproprietary name, denosumab-adet, but reference 2 products with different dosing and indications. How did Teva approach the regulatory strategy for filing 2 products from the same molecule, and why did the Xgeva approval come about 6 months after Prolia's?

Cook: The molecule is the same in the branded product, and in our biosimilars, we have denosumab-adet as the core active ingredient. There's clear regulatory alignment in making sure that we put in 2 separate BLAs [biologics license applications] to really reflect the 2 distinct products that the brand had. So although it's the same molecule, they have different dosage regimens, different presentations, and different administration schedules, so they're quite different. We wanted to make sure we're very much aligned from a regulatory perspective, and it also helps to submit them as different products to have seamless integration with clinical practices and also the payers that are acquiring these molecules for the patients.

CFB: The release doesn't mention interchangeability. Is Teva pursuing an interchangeable designation for either product, and how important is that designation now that the FDA has moved away from requiring switching studies?

Cook: Interchangeability is a legal and operational definition, but we certainly support the FDA again easing the regulatory framework away from interchangeability. You asked about whether we were granted approval, so yes: we developed the product to be interchangeable, ran the clinical studies for interchangeability, submitted for interchangeability, and received approval for interchangeability.

However, as I say, we do support the removal of interchangeability or relaxation of those requirements. That would assume that all future biosimilars and those on the market are interchangeable as a result, which will allow patients to access more affordable medicines. There'll be more competition, and it will also allow for easier handling and insurance structures at the pharmacy level.

CFB: The release highlights Teva's in-house biosimilars capabilities. What does developing and manufacturing internally, rather than through a partner, mean for quality control, batch-to-batch consistency, and Teva's ability to reliably supply both products at launch?

Cook: I'll start off with the internal program. Degevma has been approved, and that relied on a massive amount of scientific and clinical expertise and also regulatory and commercial capabilities in bringing this type of complex product to market. Teva has a long history of bringing such complex products to market. Together with Ponlimsi as the denosumab portfolio, these products offer very high batch-to-batch consistency.

They're also subject to rigorous quality control, and we ensure that we have good QA [quality assurance] oversight and that the product is suitably scaled up to supply the overall market. Those are the types of controls we have in place internally. Now, we also partner outside of Teva, as per your question, and you can take advantage of some of the complementary capabilities of these partners, work with Teva, and collaborate in those areas to bring, I'd say, a wider array of biosimilars to market than maybe just Teva could do on its own. There are advantages in partnering.

Now, whether it's internal or external doesn't make a difference in terms of quality and the commitment to regulatory requirements—the rigorous quality controls that I've mentioned, the QA oversight, all of that. The products are essentially very similar from that perspective, and we choose our partners, and our partners work with us very carefully on that.

CFB: With 10 companies now holding approved denosumab biosimilar pairs, what can a manufacturer realistically differentiate on besides price, whether that's supply reliability, presentation, or device? Is Teva developing any presentations beyond the 120-mg vial?

Cook: There is a lot of competition in biosimilars, and each company is competing very differently. Teva does have a distinct set of advantages, particularly in the biosimilar landscape for [denosumab], and I'll share 2 of them. First, we have a trusted partner approach, and that's making sure that we are committed to the growth and expansion of the biosimilars market and the sustainability of the market, making sure we're doing responsible pricing and contracting, and making sure we're operating at a suitable scale to supply the market.

That leads me on to the second point: scale of operation and supply chain reliability. Teva has decades of experience in that area. We take supply chain reliability very seriously. Continuity of supply for patients is of paramount importance, and for products like Degevma in oncology, it's even more important to make sure we have that continuity of supply.

I think that answers your question on some aspects of how we might differentiate competitively, but not all. Just to give you a flavor of that, on different presentations: No, we're not looking at different or new presentations of denosumab. More broadly, the question is relevant to future biosimilar opportunities, and we certainly look at those types of different ways of differentiating biosimilars. But really, the key take-home message is that the approval of Degevma last week, together with Ponlimsi earlier in 2026, now offers a complete portfolio of denosumab biosimilars from Teva across all indications.

Reference

1. McCrear S. Teva completes denosumab biosimilar pair with FDA nod for Degevma. The Center for Biosimilars. September 29, 2026. Accessed October 7, 2026. https://www.centerforbiosimilars.com/view/teva-completes-denosumab-biosimilar-pair-with-fda-nod-for-degevma