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Positive Results From Ustekinumab Biosimilar Phase I Trial and Infliximab Biosimilar Switching Studies

On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab).  According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara.  NeuLara…

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EMA issues positive opinion for PBP1510

Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody.  PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which…

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Biosimilars Report On Biologics and Biosimilars Market in the United States Released This Week

This week, IQVIA released an independent report on its research into the current state of the biologics market in the United States. IQVIA, formerly Quintiles and IMS Health, Inc., is a contract research organization serving the combined industries of health information technology and clinical research. In an overview of the…

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EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases

Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. Last year, we reported…

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Medicure International Enter Agreement with Reliance Life Sciences for Cardiovascular Biosimilar

Yesterday, Medicure, Inc. announced that its wholly-owned subsidiary, Medicure International Inc., has entered into a license, manufacture and supply agreement with Reliance Life Sciences Private Limited for a cardiovascular biosimilar. The identity of the biosimilar was not disclosed.  Medicure will be responsible for the regulatory approval process for the biosimilar.

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Alvotech and DKSH Extend Partnership in Asia

Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets.  The press release does not name the biosimilar candidates, but states that they “address[] multiple therapeutic areas.”  The companies previously entered into an exclusive license partnership for Alvotech’s adalimumab…

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Accord Healthcare has Launched Zercepac® (Trastuzumab) Biosimilar in the UK

Following approval by the European Commission in July, last week Accord Healthcare announced the launch of Zercepac® a biosimilar to Herceptin® in the United Kingdom.  According to the press release, Zercepac® is indicated for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and previously untreated…

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