On 24 July 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its July 2026 meeting, including positive opinions for one biosimilar and two biopharmaceuticals.
Aurobindo Pharma subsidiary, CuraTeQ Biologics, received a CHMP recommendation for Cavoley™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), as 6 mg solution for injection in a pre-filled syringe. CuraTeQ has previously had a pegfilgrastim biosimilar approved in the EU under the name Dyrupeg® (March 2025). Although it has been over 7 years since the approval of the first European pegfilgrastim biosimilar (Accord Healthcare’s Pelgraz®, September 2018), companies continue to pursue pegfilgrastim biosimilars in Europe, with Qilu Pharma obtaining a positive CHMP opinion for Nylaspeg™ (pegfilgrastim) last month.
The CHMP has also recommended marketing authorisation for Roche’s Susvimo® (ranibizumab) as a 100 mg/ml solution for injection. Susvimo® is delivered via an ocular implant (Contivue™) for continuous release into the vitreous of the eye for the treatment of nAMD. Susvimo® was approved in the US for nAMD in July 2024 and for DME in February 2025. The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.
A positive CHMP opinion was also adopted for LIB Therapeutics’ Lyrokaul® (lerodalcibep), a recombinant fusion protein containing a PCSK9 inhibitor, which is indicated for treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet. The drug was launched in the US (under the name Lerochol®) in May 2026.
At its July 2026 meeting, the CHMP also recommended expanded indications for a number of medicines, including:
- AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for unresectable or metastatic HER2 positive breast cancer (in combination with pertuzumab);
- Amgen’s Repatha® (evolocumab) for adults with established, or at high risk for, atherosclerotic cardiovascular disease; and
- Gilead’s Trodelvy® (sacituzumab govitecan), in combination with pembrolizumab, for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score ≥ 10.