On 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026 meeting, including positive opinions for the following two biosimilars.
- Alvotech/Advanz’s Adcomfo® (omalizumab)
Alvotech/Advanz Pharma’s Adcomfo® (AVT23/ADL-018), biosimilar to Genentech/Novartis’ Xolair® (omalizumab), is recommended for approval in 75 mg, 150 mg and 300 mg solution for injection in a pre-filled syringe (PFS) or pre-filled pen (PFP). The CHMP opinion follows EMA acceptance of the marketing authorisation application for AVT23 in October 2025.
Adcomfo® was developed by Alvotech in collaboration with Kashiv Biosciences and is the subject of an October 2023 licensing agreement under which Advanz Pharma has exclusive commercialisation rights for the European Economic Area (European Union, Norway, Iceland and Lichtenstein), the UK, Switzerland, Canada, Australia and New Zealand. A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.
Celltrion’s Omlyclo® was the first (and to date remains the only) omalizumab biosimilar to be approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation in November 2025. Celltrion commenced its European rollout of Omlyclo® (75 mg/0.5 mL and 150 mg/1 mL) in Norway in September 2025, and completed the launch of those formulations in major European countries including Germany, Spain, the UK and France in November 2025.
Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026. Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.
- Biocon’s Pebrilzo® (pertuzumab)
The CHMP has also recommended Biocon’s Pebrilzo® (Bmab 1500), biosimilar to Roche/Genentech’s Perjeta® (pertuzumab), for the treatment of HER-2 positive breast cancer (420 mg concentrate for solution for infusion).
Pebrilzo® follows Shanghai Henlius/Organon’s pertuzumab biosimilar, Poherdy®, which was approved in Europe in April 2026 (and in the US (November 2025) and China (as Hanbeiyou®, May 2026)).
Biocon is currently being sued by Roche/Genentech in the US in relation to Bmab 1500, with BPCIA proceedings commenced in July 2026. Roche/Genentech allege Biocon infringes 28 US patents for inventions related to Perjeta® and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture. Genentech also filed an ITC complaint in February 2026 against Biocon’s importation of Bmab 1500 into the US.
Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024) and Enzene’s Pertuza®/Perzea® (launched September 2025). In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved. Litigation has been brought by Roche/Genentech against Biocad in Russia and Zydus in India.
In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan. This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.