CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for 3 biosimilars as well as some reference products with pending indication expansions, providing hope for patients in need of greater biologics access.

Getting the thumbs up from the Eureopean Medicines Agency's CHMP is the penultimate step of the European Union (EU) drug approval process, preceding the European Commission's (EC) final approval. | Image credit: Brenda Blossom - stock.adobe.com

Getting a positive opinion from the CHMP is the penultimate step of the European Union (EU) drug approval process, followed only by the European Commission (EC) granting its final approval. At the end of January, the committee shared its meeting highlights, covering recommendations for 8 new medications and a positive opinion for 1 medication intended for use outside of the EU. The meeting updates also highlighted 2 application withdrawals.¹

Biosimilars Progressing to the Next Stage

One aflibercept biosimilar and 1 pegfilgrastim biosimilar are moving on to be reviewed by the EC.

Aflibercept products, which reference Eylea (aflibercept), are anti–vascular endothelial growth factor agents used to treat retinal conditions like diabetic macular edema and neovascular age-related macular degeneration.³ Out of the present meeting, the CHMP gave a positive recommendation for the approval of Amgen’s aflibercept, which will be marketed as Pavblu and Skojoy depending on European country.¹ If given final authorization, the biosimilar will join 2 other aflibercept biosimilars: Opuviz (Samsung Bioepis/Biogen) and Yesafili (Biocon).⁴

In the supportive care space, the CHMP recommended CuraTeQ Biologics’ Dyrupeg, a biosimilar to Neulasta (pegfilgrastim), for approval.¹ Pegfilgrastim products are administered in combination with chemotherapy to prevent or treat febrile neutropenia, a common and life-threatening condition associated with low white blood cell counts resulting from chemotherapy.⁵

If given final approval, it will join Cegfila/Pelmeg (Mundipharma), Fulphila (Viatris), Grasutek (Juta Pharma), Nyvepria (Pfizer), Pelgraz (Accord Biopharma), Stimufend (Fresenius Kabi), and Ziextenzo (Sandoz).⁴

Additionally, the CHMP recommended a generic eltrombopag from Accord Healthcare for approval.¹ If all goes well with the EC, the generic will be used to treat primary immune thrombocytopenia and chronic hepatitis C virus.

New Indications for Originators Prepping for Biosimilar Competition

Nivolumab (Opdivo) and ipilimumab (Yervoy) were both recommended by the CHMP for hepatocellular carcinoma (HCC). The drugs, approved for use together, have previously been indicated for unresectable or metastatic melanoma, melanoma as adjuvant treatment, resectable or metastatic non–small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and esophageal cancer.^6,7

Currently, several biosimilars for both products are in development, including candidates being developed by Innovent Biologics, Amgen, and Xbrane Biopharma among others.^8-10 However, they’re not likely to launch until at least 2028.⁹

A study on HCC in Europe found the highest age-standardized incidence in Southern Europe (n = 12 in every 100,000 men and 3 in every 100,000 women from 1992-1994) and the lowest in Northern Europe, where rates were similar to those in the United States (n = 3 in every 100,000 men; less than 1 in every 100,000 women).¹¹

If Opdivo and Yervoy pass the final round, their new indication will expand the reach of future biosimilars, providing greater savings for European health systems and providing greater medication access to patients in Europe with HCC.¹

References

1. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. European Medicines Agency. January 31, 2025. Accessed February 6, 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2025

2. Obtaining an EU marketing authorisation, step-by-step. European Medicines Agency. Accessed February 6, 2025. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step#assessment-of-the-application-13176

3. Aflibercept injection. Medline Plus. Updated July 20, 2024. Accessed February 6, 2025. https://medlineplus.gov/druginfo/meds/a612004.html

4. Biosimilar approvals. The Center for Biosimilars. Updated January 7, 2025. Accessed February 6, 2025. https://www.centerforbiosimilars.com/biosimilar-approvals

5. Pegfilgrastim injection. Medline Plus. Updated June 20, 2024. Accessed February 6, 2025. https://medlineplus.gov/druginfo/meds/a607058.html

6. Opdivo - opinion on variation to marketing authorization. European Medicines Agency. January 30, 2025. Accessed February 6, 2025. https://www.ema.europa.eu/en/medicines/human/variation/opdivo-3

7. Yervoy - opinion on variation to marketing authorization. European Medicines Agency. January 30, 2025. Accessed February 6, 2025. https://www.ema.europa.eu/en/medicines/human/variation/yervoy-0

8. Ipilimumab biosimilar by Innovent Biologics for metastatic biliary tract cancer: likelihood of approval. Updated December 4, 2024. Accessed February 6, 2025. https://www.pharmaceutical-technology.com/data-insights/ipilimumab-biosimilar-innovent-biologics-metastatic-biliary-tract-cancer-likelihood-of-approval/

9. Brennan Z. Amgen readies PhIII trial for first Opdivo biosimilar, with launch unlikely before 2028. September 27, 2023. Accessed February 6, 2025. https://endpts.com/amgen-readies-phiii-trial-for-first-opdivo-biosimilar-with-launch-unlikely-before-2028/

10. Xbrane successfully scales up Xdivane^™- biosimilar candidate to Opdivo^® – and run an active partnering process. Press release. XBrane Biopharma; May 22, 2024. Accessed February 6, 2025. https://xbrane.com/en/mfn_news/xbrane-successfully-scales-up-xdivane-biosimilar-candidate-to-opdivo-and-run-an-active-partnering-process

11. Capocaccia R, Sant M, Berrino F, et al. Hepatocellular carcinoma: trends of incidence and survival in Europe and the United States at the end of the 20th century. Am J Gastroenterol. 2007;102(8):1661-1670. doi:10.1111/j.1572-0241.2007.01337.x