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A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.

On Friday, the US Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it m...

Accord Healthcare was the clear winner at the Global Generics and Biosimilars Awards which were presented on 2 November in Frankfurt, achieving “Biosimilar Initiative of the Year”, “Company of the Year”, “Value Added Medicine Initiative of the Year”, and “Regulatory Achieve...

Bio-Thera Solutions announced that it has commenced Ph III trials of BAT2306, biosimilar to Novartis’ secukinumab (Cosentyx®) in patients with moderate to severe plaque psoriasis.

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...