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Australia’s PBAC reversed the temporary COVID measures put in place in response to drug shortages during the COVID pandemic allowing patients to transition off tocilizumab during the shortage period to another biological disease modifying drug (bDMARD) claiming that “as of ...

Significant biosimilar activities this week include:

28 Oct 22 | Health Canada approves additional COVID-19 indication for Actemra® IV (tocilizumab)

Roche Canada announced that Health Canada has approved Actemra® IV (tocilizumab) for the treatment of hospital...

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
Tysabr...

Roche Canada announced that Health Canada has approved Actemra® IV (tocilizumab) for the treatment of hospitalised adult patients with COVID-19 who are receiving systemic corticosteroids, and require supplemental oxygen, non-invasive or invasive mechanical ventilation or ex...

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...