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Significant biosimilar activities this week include:

21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™

Spectrum Pharmaceuticals announced the US launch of Rolvedon™ (eflapegrastim-xnst), a market which is estimated to be valued at over US$2B.  Rolv...

Rani Therapeutics announced that it has commenced preclinical development of RT-111 a RaniPill GO capsule containing an ustekinumab biosimilar.  BioFactura and Rani Therapeutics entered into an agreement in September 2021 to assess Bio-Thera’s BFI-751 (ustekinumab biosimila...

Regeneron announced that the FDA has granted paediatric exclusivity for Eylea® (aflibercept), extending market exclusivity in the US to 17 May 2024. Paediatric exclusivity was granted on the basis of Ph III trials of Eylea as a treatment for retinopathy of prematurity in pr...

Spectrum Pharmaceuticals announced the US launch of Rolvedon™ (eflapegrastim-xnst), a market which is estimated to be valued at over US$2B.  Rolvedon was FDA approved in September 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in adult pa...

AbbVie announced the acquisition of DJS Antibodies, a UK-based biotechnology company.  DJS’ lead program is DJS-002, a lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently under investigation for the treatment of Idiopathic Pulmonary Fibrosis (IPF) a...

The Saskatchewan Ministry of Health announced the introduction of a biosimilar switching program – the 6th of its kind to be introduced into provinces/territories in Canada. Under the new program, the Saskatchewan Drug Plan will only cover listed biosimilars for new patient...

Alvotech announced that it has expanded its exclusive partnership with JAMP for Canada, adding AVT16 (immunology biosimilar) and AVT33 (oncology biosimilar) to their existing partnership.  Under the agreement, Alvotech will be responsible for the development and commercial ...

Lupin disclosed that the FDA has issued 17 observations in relation to its biotech manufacturing facility in Pune, India.  Lupin announced that it is committed to addressing the concerns raised by the FDA, and that it does not expect the observations to impact on the existi...

Former Genentech scientist Xanthe Lam and her husband Allen Lam were each sentenced to six months imprisonment and fines of over $10,000 for their role in the Genentech/JHL Biotech trade secrets scandal.  The Lams plead guilty to stealing confidential intellectual property ...

Biocon Biologics announced that it will license its ustekinumab and denosumab biosimilars to Yoshindo for Japan.  Yoshindo will pay an upfront licence fee and further payments over the next few years as certain development milestones are achieved. Biocon Biologics estimates...