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Outlook Therapeutics announced that the FDA has accepted its BLA for ONS-5010 (ophthalmic bevacizumab biosimilar) for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

Biogen is seeking a preliminary injunction in its proceedings against Sandoz commenced in September 2022 relating to natalizumab.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.  Biogen filed a sealed...

Alvotech announced that it will release financial results for the first nine months of 2022 on 15 November 2022.  Following the release, Alvotech will conduct a business update conference call and live webcast.

In October 2022, Fresenius Kabi entered into a confidential settlement agreement with Chugai and Roche, which resulted in the termination of seven Inter Partes Review proceedings in relation to tocilizumab patents.  The IPRs were commenced by Fresenius in 2021 and 2022.  At...

A trial date of 12 – 23 June 2023 has been set in the Regeneron v Mylan aflibercept District Court (NDWV) BPCIA dispute.  Regeneron has identified 6 patents (10,888,601, 11,053,280, 11,084,865, 11,104,715, 11,253,572 and 11,299,532) from 3 patent families for initial procee...

JSR Life Sciences announced that its recently launched biosimilars business Similis Bio has entered into a development and licence agreement with Blau Farmaceutica for four biosimilar products targeting oncology, inflammation and blood disorders.  Under the agreement, Simil...

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...