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Celltrion announced that the FDA has approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent...

On 26 September 2022, Sanofi’s oppositions to five Amgen patent applications were held to be unsuccessful by the Australian Patent Office.  The patent applications (AU2013203677, AU2013203685, AU2013203689, AU2013203748, AU2013203751) relate to antigen binding proteins to p...

Significant biosimilar activities this week include:

22 Sep 22 | CH | STADA launches Alvotech’s Hukyndra® (100mg/mL adalimumab) in Switzerland

Alvotech and STADA announced the launch of Hukyndra® (100mg/mL, citrate free biosimilar adalimumab) in Switzerland.  ...

The Australian Department of Health and Aged Care announced that from 1 October 2022 Keytruda (pembrolizumab) will be included in the Australian Pharmaceutical Benefits Scheme (PBS) for the treatment of squamous cell carcinoma of the head and neck.   The Health Minister rep...

AstraZeneca and Merck (“MSD” outside North America) announced that China’s NMP has approved Lynparza® (olaparib) as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or parti...

Alvotech and STADA announced the launch of Hukyndra® (100mg/mL, citrate free biosimilar adalimumab) in Switzerland.  Alvotech reached a settlement with AbbVie in April 2022, enabling the launch of adalimumab across Europe, and STADA has since launched Hukyndra in several Eu...

Korea Biomedical Review reported that Celltrion has successfully invalidated a Taiwanese Roche rituximab patent relating to the treatment of rheumatoid arthritis.  Celltrion reported that it will now expand its label in Taiwan to include all indications of Rituxan®.

AVEO Oncology announced that the FDA has granted fast track designation to ficlatuzumab (its investigational humanized IgG1 mAb targeting hepatocyte growth factor) for the treatment of relapsed or recurrent head and neck squamous cell carcinoma.

Significant biosimilar activities this week include:

07 Sep 22 | Celltrion’s ustekinumab biosimilar Ph III trials

Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable efficacy and safety to Janssen’s ...