• Naomi Pearce & Emily Bristow

Pearce IP BioBlast: w/e 12 June 2020

Significant biosimilar activities this week include:

  • June 08: the Centre for Biosimilars reported that the WHO certified Celltrion's Truxima® (rituximab) in its prequalification program. This program assesses clinical and other data related to biosimilars, and aims to guide low-income countries in their selection of medicines, vaccines and technologies for national procurement.

  • June 08: Xbrane Pharma announced that it has entered into an agreement with Akademiska Hus for the lease of new premises at Campus Solna. From March 2021, Xbrane will establish a new development lab for biosimilars and will move their headquarters to the new campus at Solna. Xbrane has said that the new development lab will give them expanded capacity and the ability to start development of additional biosimilar candidates.

  • June 09: Sandoz announced Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

  • June 09: the Big Molecule Watch reported that a US District Court Judge ruled AbbVie's conduct in relation to its blockbuster Humira® (adalimumab), while preventing competitors from reaching the market in the US, was not illegal. The action was filed against AbbVie by a number of parties including the City of Baltimore and a pension for Police Officers, and alleges that by amassing a 'patent thicket' and settling litigation with competitors which prevented them launching in the US, AbbVie had engaged in conduct which breached federal and state antitrust laws.

  • June 10: the University of Oxford announced Celltrion's infliximab biosimilar CT-P13 (Inflectra, Remsima) would be one of the products trialled in the CATALYST Study. This study is examining possible treatments for patients with COVID-19. It is hoped that the CT-P13 will prevent the immune system response which leads to cytokine storm syndrome in COVID patients.

  • June 11: Pfizer announced FDA has approved Nyvepria® (pegfilgrastim). Nyvepria® is indicated to decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

  • June 11: a new study published in BMC Rheumatology reported that Hetero's biosimilar adalimumab Mabura® was effective and well tolerated in comparison to Humira in patients with active rheumatoid arthritis.

  • June 11: Celltrion announced a $278 million deal to acquire Takeda Pharmaceuticals Primary Care businesses in the Asia Pacific. Under the agreement, Celltrion will gain access to patent, trademark and marketing rights for 18 prescription and over-the-counter brands in 9 markets including South Korea, Thailand, Taiwan, Hong Kong, Singapore and Australia.

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