Significant biosimilar activities this week include:
07 Jan 23 | Biocon receives complete response letter over insulin-r product.
Biocon announced that it has received a complete response letter (CRL) from the FDA in relation to its insulin-r product. Biocon reported that the CRL cites additional data required and that it is in the process of addressing the CRL.
06 Jan 23 | FDA accepts BLA for Alvotech’s AVT04 (biosimilar ustekinumab)
Alvotech and Teva announced that the FDA has accepted for review a BLA for AVT04 (biosimilar ustekinumab). Alvotech reported that it expects the review to be completed in the second half of 2023. AVT04 is being developed under a strategic agreement between Alvotech and Teva announced in August 2020.
05 Jan 23 | CA | Health Canada approves Vegzelma™ (biosimilar bevacizumab)
Korea Biomedical Review reported that Celltrion has obtained approval from Health Canada for CT-P16/Vegzelma® (biosimilar bevacizumab) for the same indications as Avastin®. Celltrion obtained approval for Vegzelma in the US in September 2022. Vegzelma is Celltrion’s third anticancer drug, after Truxima® (biosimilar rituximab) and Herzuma® (biosimilar trastuzumab).
04 Jan 23 | Lannett provides update on biosimilar insulin aspart and insulin glargine products
Lannett provided an update on its biosimilar insulin aspart and insulin glargine products. Lannett reported that its study of its biosimilar insulin aspart product indicated that the product was highly comparable with NovoLog®. Lannett announced that it plans to file the BLA for its insulin aspart product by the end of 2024, with a potential launch in 2025, and plans to file the BLA for its insulin glargine product by mid-year 2023, with a potential launch late in the first half of 2024.
03 Jan 23 | Hikma and Celltrion sign agreement for Vegzelma® (biosimilar bevacizumab)
Hikma Pharmaceuticals announced that is has signed an exclusive licensing agreement with Celltrion for Vegzelma® (biosimilar bevacizumab CT-P16) for MENA (Middle East and North Africa) markets. Vegzelma is approved in the US and CA, and is the seventh biosimilar to be licensed by Celltrion to Hikma, following Truxima® (rituximab), Remsima® (intravenous infliximab), Herzuma® (trastuzumab), Remsima® SC (subcutaneous infliximab), Yuflyma™ (adalimumab), and CT-P43 (ustekinumab). The deals regarding CT-P43 (biosimilar ustekinumab) and Yuflyma™ (biosimilar adalimumab) were announced in 2022.
03 Jan 23 | CA | Health Canada approves Samsung Bioepis’ high concentration Hadlima® (biosimilar adalimumab)
Samsung Bioepis announced that Health Canada has approved its high concentration, citrate-free (100mg/mL) Hadlima® (biosimilar adalimumab) following FDA approval in August 2022.
02 Jan 23 | Alteogen and Sandoz sign exclusive licence agreement
Alteogen announced that it has entered into an exclusive licence agreement with Sandoz for the use of ALT-B4 (novel hyaluronidase derived using Alteogen’s Hybrozyme™ technology) to develop a subcutaneous version of an undisclosed Sandoz biosimilar product. The agreement also includes an option for Sandoz to licence the Hybrozyme technology for two further products. Alteogen will receive an upfront payment and is eligible to receive milestone payments and tiered royalties on sales of the commercialised products. Alteogen will be responsible for the regulatory development and commercial supply of ALT-B4 to Sandoz.
01 Jan 23 | US | Samsung Bioepis speeds up interchangeability study of Hadlima® (biosimilar adalimumab)
The Korea Herald reported that Samsung Bioepis has brought forward its interchangeability study of Hadlima® (biosimilar adalimumab). Samsung had previously announced that it would complete the study by September 2023, however now plans to complete the study in May 2023. Samsung reported that Organon will launch in the US by July 2023 in accordance with its settlement agreement with AbbVie, without an interchangeable designation.
01 Jan 23 | US | Amgen able to launch Amgevita® from 31 January 2023
Amgen’s Amgevita® is due to become the first biosimilar adalimumab in the US market, with a launch possible from 31 January 2023, in accordance with its settlement agreement with AbbVie. Amgevita was launched in Europe in 2018, Canada in 2021 and Australia in 2021.
30 Dec 22 | First patient dosed in ONC-392 (nextgen target-preserving anti-CTLA-4 antibody) and Keytruda® (pembrolizumab)
OncoC4 announced that the first patient has been dosed in Ph II trials of ONC-392 (nextgen target-preserving anti-CTLA-4 antibody) and Keytruda® (pembrolizumab) in patients with platinum-resistant ovarian cancer. The study is sponsored by OncoC4 in collaboration with Merck and GOG Foundation Inc.
22 Dec 22 | US | Celltrion submits BLA for CT-P13 SC (subcutaneous biosimilar infliximab)
Celltrion announced that it has submitted a BLA for CT-P13 SC (subcutaneous biosimilar infliximab) with the FDA. CT-P13 is the first and only known infliximab to have both intravenous and subcutaneous formulations.
22 Dec 22 | US | Alvotech announces new BsUFA end date for AVT02 (biosimilar adalimumab)
Alvotech announced that the FDA has granted a new Biosimilar User Fee Amendment goal date of 13 April 2023 for its AVT02 (biosimilar adalimumab), and that FDA has confirmed that the data provided are sufficient to support a determination of interchangeability, subject to a site reinspection. Alvotech is licensed to supply AVT02 in the US from 01 July 2023 in accordance with a licence agreement with AbbVie.
20 Dec 22 | CA | Ontario adopts biosimilars switching program
Ontario announced that it will adopt a biosimilars switching program from 31 March 2023. Patients currently treated with Copaxone® (glatiramer acetate), Enbrel® (etanercept), Humalog® (insulin lispro), Humira® (adalimumab), Lantus® (insulin glargine), NovoRapid® (insulin aspart), Remicade® (infliximab), and Rituxan® (rituximab) will be required to transition to the biosimilar version by 29 December 2023. Ontario is the 8th jurisdiction to adopt a biosimilars switching program, following British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan.
19 Dec 22 | Dr Reddy’s announces results of Ph I trials of biosimilar tocilizumab
Dr Reddy’s announced that DRL_TC (biosimilar tocilizumab) met is primary and secondary endpoints in Ph I trials. Dr Reddy’s is developing DRL_TC in both subcutaneous and intravenous formulations.
12 Dec 22 | EU | EMA reviewing biosimilar ustekinumab application
The EMA reported that it is reviewing an application for biosimilar ustekinumab. If approved, this will be the first ustekinumab biosimilar approved in the EU.
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