04 Jul 22 | US | Xbrane Biopharma provides update on ranibizumab biosimilar
Xbrane Biopharma confirmed that it will resubmit a BLA for its biosimilar to Lucentis® (ranibizumab) this year. Xbrane previously announced that it would withdraw the BLA after receiving feedback from the FDA in May that additional information was required for the FDA to accept the BLA and initiate a review.
05 Jul 22 | US | Viatris voluntarily recalls one US batch of biosimilar insulin glargine due to missing labels
Viatris announced that it was voluntarily recalling one batch of insulin glargine 100 units/mL, 3mL prefilled pens (batch BF21002895) due to the potential for the label to be missing on some pens. This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens. The batch was manufactured by Biocon, and sold in the US between 4 April 2022 and 5 May 2022.
05 Jul 22 | Alvotech board of directors approves increase of share capital and creation of treasury share pool
Following Alvotech’s listing on the NASDAQ and NASDAQ First North growth market last month, the board of directors has approved an increase in its share capital by an amount of $270,721.67 through the issuance of 27,072,167 ordinary shares. The share capital increase was executed to facilitate the Company’s obligations (a) in relation to the public and private warrants assumed as a consequence of the business combination with Oaktree Acquisition Corp announced in December 2021, (b) under its management incentive plan.
06 Jul 22 | US | FDA grants priority review to Roche’s Lunsumio® in relapsed or refractory follicular lymphoma
Roche announced that the FDA has accepted the BLA and granted priority review for Roche’s Lunsumio® (mosunetuzumab) (potential first-in-class CD20xCD3 T-cell engaging bispecific antibody) for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior systematic therapies. The FDA is expected to a make a decision by 29 December 2022.
06 Jul 22 | AU | PBAC considers 5 biosimilar applications
At the PBAC meetings 6 – 8 July, Australia’s PBAC considered a number of applications for biologic and biosimilar products, including:
- Celltrion’s Yuflyma® (biosimilar adalimumab): requesting listing under the same conditions as Humira®;
- Pfizer’s Zirabev® (biosimilar bevacizumab): reviewing positive recommendations not accepted by Pfizer.
- Biogen’s Tysabri® (natalizumab): requesting removal of the clinical criterion which requires neurologists prescribing natalizumab under the PBS to be registered with the Tysabri Australian Prescribing Program;
- BMS’ Opdivo® (nivolumab): requesting a s100 Authority Required listing for adjuvant treatment of patients who have undergone radical resection of muscle invasive urothelial carcinoma originating in the bladder or upper urinary tract and are at high risk of recurrence;
- AbbVie’s Skyrizi® (risankizumab): requesting General Schedule Authority Required listings for the treatment of severe Crohn’s disease and for complex refractory fistulising Crohn’s disease;
- AstraZeneca’s Enhertu® (trastuzumab deruxtecan): requesting a Section 100 Authority Required listing for the treatment of human epidermal growth factor receptor 2 positive (HER2) metastatic breast cancer in patients whose disease has progressed following treatment with at least one prior HER2-directed regimen in the metastatic setting or whose disease has progressed during or within 6 months following HER2-directed adjuvant treatment;
- Janssen’s Stelara® (ustekinumab): requesting a General Schedule Authority Required listing of a new form for the treatment of patients with Crohn disease and chronic plaque psoriasis; and
07 Jul 22 | Alvotech commences clinical trials for AVT06 (proposed aflibercept/Eylea® biosimilar)
Alvotech announced the initiation of its ALVOEYE clinical trials for AVT06, biosimilar to Eylea® (aflibercept) which is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration (AMD). AVT06 is the third Alvotech biosimilar product to enter the clinic, and is one of eight products under development.
Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.
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