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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...

Alvotech announced that Fuji Pharma has submitted a marketing authorisation application to Japan’s Ministry of Health, Labor and Welfare for an undisclosed product.  This is the first MAA to be submitted under the exclusive partnership agreement between Alvotech and Fuji Ph...

Significant biosimilar activities this week include:

14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable PK to Stelara® in Ph I trial

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BF...

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751.  The trial in Australia and New Zealand involved 226 subjects and demonstrated bioequivalence of BFI-751 to the US and EU versions of Janssen’s Stelara.  ...

Prestige Biopharma announced that it has submitted a request to the FDA for a pre-submission meeting to discuss the planned BLA for Tuznue® (biosimilar trastuzumab).  Prestige announced that it plans to submit the BLA by the end of the year.