Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.
Sandoz has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz' biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
"We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines," said Mark Levick, Global Head of Development, Biopharmaceuticals, Sandoz. "Today's recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios".
If approved, Sandoz biosimilar rituximab may be used in all indications of the reference medicine, MabThera, which are non-Hodgkin's lymphoma - follicular lymphoma and diffuse large B-cell lymphoma - chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
If Sandoz biosimilar etanercept is approved, it may be used in all indications of the reference medicine, Enbrel, which are rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, psoriatic arthritis, Juvenile idiopathic arthritis and pediatric plaque psoriasis.
The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical - including pharmacokinetic/pharmacodynamic - data were generated. The programs demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines.
Related News
-
News Novartis signs US$3.2 bn subcutaneous delivery deal with Alteogen
Swiss pharma giant secures access to Korean biotech's ALT-B4 hyaluronidase platform in milestone-heavy agreement, marking Alteogen's fourth major licensing deal of 2026 as competition intensifies in the subcutaneous drug delivery space.
-
News Women in Pharma: The philosophy of pharmaceutical leadership
In this latest instalment of our Women in Pharma series, we sit down with Clarissa Sowemimo-Coker, Chief Strategy Officer at Ambrose Healthcare and CPHI Middle East Advisory Board Member.
-
News The PSCI Supplier Partnership - Collaboration for Responsible Supply Chains
About the Pharmaceutical Supply Chain Initiative The Pharmaceutical Supply Chain Initiative (PSCI) is the leading, member-led association for pharmaceutical companies working collaboratively to build responsible supply chains. Founded in 2006 and es... -
News AstraZeneca shares plunge 8.9% after reports of BMS talks
Britain's largest drugmaker lost more than GBP£17 billion in market value following reports of preliminary merger discussions with Bristol Myers Squibb that could create a pharmaceutical giant worth nearly US$400 billion, though investors rem... -
News GSK announces £400 million investment in new Cambridge R&D centre
Pharmaceutical giant to establish flagship research facility on Cambridge Biomedical Campus as part of strategic pipeline acceleration
-
News The CPHI Sustainability Summit - Where Conversation Becomes Collaboration
The Report Was Never the Destination - “The future of pharmaceutical sustainability won’t be shaped by individual organisations working in isolation. It will be shaped by partnerships, shared expertise and the willingness to work diffe... -
News Trump's generic drug tariffs set to reshape global pharmaceutical supply chains
The US president has announced plans to impose tariffs of up to 200% on imported generic medicines from August 2028, giving manufacturers a two-year window to establish domestic production facilities. The move threatens to upend a global supply chain t... -
News Building Safer, More Responsible Pharmaceutical Supply Chains: PSCI Global Audit Insights
The Pharmaceutical Supply Chain Initiative (PSCI) has released its seventh annual Audit Findings Analysis Report, offering unprecedented insights into supplier practices across the global pharmaceutical and healthcare industry.With a record-breaking 24...