Six Biosimilars Part of EMA’s Authorization Recommendations in June

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 13 medicines for marketing authorization at its June 16–19 meeting (1). Among the authorized medicines are six biosimilars and two generic drugs. These approvals bring the total medicines approved for authorization in 2025 so far to 56.

Austedo (deutetrabenazine) was granted marketing authorization for the treatment of adults with moderate-to-severe tardive dyskinesia. Patients with tardive dyskinesia experience abnormal involuntary movements resulting from chronic or episodic exposure to dopamine receptor antagonists.

Positive opinion was given to Imreplys (sargramostim) for the treatment of hematopoietic acute radiation syndrome, when bone marrow does not produce enough blood cells, leading to infection and bleeding, after exposure to radiation. The authorization was given under exceptional circumstances, due to the rarity of the condition and lack of comprehensive data (2).

The orphan drug, Ogsiveo (nirogacestat), was approved for the treatment of adults with progressing desmoid tumors. These are soft tissue tumors that form in fibrous tissue in areas such as the abdomen, arms, and legs, but do not spread to other locations.

Zemcelpro (dorocubicel/unexpanded umbilical cord cells) was granted conditional marketing authorization for the treatment of adults with hematological malignancies (blood cell cancers). Zemcelpro is used to treat patients that require allogeneic hematopoietic stem cell transplantation following chemotherapy or radiotherapy when no other type of suitable donor cells is available.

EMA also granted conditional marketing authorization to Rezdiffra (resmetirom) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH). MASH is a condition where fat cells accumulate in the liver and cause chronic inflammation. Currently, there are no authorized treatments for metabolic dysfunction-associated steatohepatitis in the European Union.

The following six biosimilars were given a positive opinion at the June meeting:

• treatments for treatment of age-related macular degeneration and visual impairment: Mynzepli (aflibercept), and its duplicate Afiveg (aflibercept), Vgenfli (aflibercept), and its duplicate Eiyzey (aflibercept)
• Usymro (ustekinumab) for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn’s Disease
• Vivlipeg (pegfilgrastim) to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

Two generic drugs were also approved. Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris (emtricitabine/rilpivirine/tenofovir alafenamide) was approved to treat adults and adolescents with HIV type 1. Nintedanib Viatris (nintedanib) was approved for the treatment of idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis associated with interstitial lung disease.

CHMP also extended indications for Benlysta, Cabometyx, Darzalex, Imbruvica, Nubeqa, and Sarclisa. The indication for use of Dapivirine Vaginal Ring 25 mg (dapivirine) outside of the EU and by women 16 years of age was also extended.

In addition, at the meeting, CHMP announced that it is re-examining its negative opinion on Atropine sulfate FGK (atropine), a medicine intended to slow myopia progression in children aged 6 to 10 years with spherical equivalent refraction in the range of -0.50 to ‑6.00 diopter. It is also re-examining its negative opinion on the Alzheimer’s disease drug, Kisunla (donanemab).

References

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 16–19 June 2025. Press Release. June 20, 2025.

2. EMA. Exceptional Circumstances. Ema.europa.eu (accessed June 23, 2025). https://www.ema.europa.eu/en/glossary-terms/exceptional-circumstances