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The International Generic and Biosimilar Medicines Association has urged the World Intellectual Property Organization to withdraw its support for a global database of pharmaceutical patent information. The Pat-INFORMED database – which is comprised of intellectual-property information provided by originators – contains unverified data and lacks appropriate safeguards, the IGBA contends.
China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.
The first of around 260 patients for a clinical trial comparing its PB006 natalizumab biosimilar candidate to Biogen’s Tysabri reference brand have been recruited by Polpharma Biologics, which has just added Karsten Roth and Alexandra Moulson to its team.
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.
Industry associations in the US and Canada have welcomed revisions to the proposed US-Mexico-Canada trade agreement that remove potentially damaging provisions around biologic data exclusivity and include measures favorable to generics, including incentives for generic competition.
NeuClone has reported that its NeuCeptin proposed biosimilar trastuzumab has successfully met all primary and secondary endpoints in a Phase I clinical trial.
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