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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.

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STAT+: Belgian anti-trust authorities probe Roche for allegedly delaying biosimilars of two cancer meds

STAT

Belgian anti-trust regulators are probing Roche over concerns that the drug company took steps to delay the entry of biosimilar versions of two of its cancer medicines. The agency also maintained Roche disseminated “erroneous information” about using biosimilars in combination therapy.

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EU approves Biocon Biologics’ Denosumab biosimilars

Express Pharma

Biocon Biologics announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab. Clinical data showed that both Denosumab biosimilars have comparable quality, safety, and efficacy to the reference product.

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Health Canada approves Biocon Biologics’ YESAFILI, first EYLEA biosimilar, for launch in July 2025

Express Pharma

Biocon Biologics (BBL), a biosimilars company and subsidiary of Biocon, has announced that Health Canada has granted a Notice of Compliance (NOC) for YESAFILI (aflibercept), a biosimilar to EYLEA (aflibercept) injection. YESAFILI is the first biosimilar to EYLEA to be approved by Health Canada.

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Sandoz breaks ground on new European biosimilar plant

European Pharmaceutical Review

Sandoz has begun construction of a new biosimilars production facility in Brnik, Slovenia. The new high-tech facility will produce both existing and upcoming biosimilar medicines in Sandoz’s portfolio. . Ensuring a reliable supply of biosimilars in Europe “… With a commitment of over $1.1

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Panel Discussion: Biologics and biosimilars: The next leap in patient-centric drug development

Express Pharma

3] The ultimate objective of biosimilar development should be to enhance patient outcomes through accessible, effective, and user-friendly therapies. [4] 4] Future biologics and biosimilars should prioritize self-administration capabilities, empowering patients and improving adherence. [5]

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Kashiv BioSciences Reports Positive Topline Results for XOLAIR® Biosimilar Candidate ADL-018

Big Molecule Watch

On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria.