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Pearce IP BioBlast®: w/e 23 July 2021

by | Jul 26, 2021

19 Jul 21 | Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration.

19 Jul 21 | Samsung Bioepis announced that it has commenced Ph III trials of SB17 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

20 Jul 21 | Sorrento announced that China’s NMPA has granted marketing approval for Mabpharm’s infliximab ‘biobetter’. Sorrento holds exclusive commercial rights to the product outside of China and disclosed that it plans to file a BLA in the EU and US in 2021.

22 Jul 21 | Inhalon Biopharma announced it will partner with Celltrion to develop IN-006, an inhaled form of regdanvimab for the treatment of COVID-19. It is hoped that the product will be able to reach the virus in the airways and allow patients to self-administer treatment at home. Last week we reported that regdanvimab demonstrated strong neutralising activity against the Delta variant of COVID-19 in pre-clinical studies.

22 Jul 21 | Intas Pharma announced it has signed a commercialisation agreement with Meiji and Dong-A St for DMB-3115 (proposed ustekinumab biosimilar). Under the agreement, Intas will receive exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.

22 Jul 21 | A new study published in Rheumatology reported that the safety and efficacy of Celltrion’s CT-P17 (biosimilar adalimumab) were comparable after one year of treatment, including for patients who switched from reference adalimumab after 24 weeks.

23 Jul 21 | US | Pfizer and Johnson & Johnson (J&J) settled the antitrust litigation relating to Pfizer’s Inflectra® (infliximab biosimilar). Pfizer had alleged that J&J’s payer contracts restricted the use of Inflectra® by denying reimbursement unless Remicade was first proven ineffective for patients, causing a reluctance among pharmacies to stock Inflectra®. Details of the settlement have not been published.

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