PCI 7 November 2023, 15:22
Thermofisher: Thu 29 February 2024, 11:15
BMG Labtech: Wed 18 September 2024, 11:55
Owen Mumford 12 January 2022, 16:46

Current Edition

Cell and Gene Therapy

Upcoming Events

NextGen BioMed – 04/02/2025
BioTrinity 2025 – January 30th 2025
Elrig R&I 2025 – 27th January 2025
Biotechnology Show 2025: 20th January 2025
Anglonordic: 16th January 2025
AI in Drug Discovery – SAE media – January 14th 2025

Advertisement

Fujifilm rectangle: Fri 22 November 2024, 14:23
Roald Dahl Charity: Fri 15 November 2024, 12:57
A&M STABTEST: Fri 21 June 2024, 11:43
CDD Vault: Wed 17 July 2024, 11:46
Aurisco – 04/02/2025

Pfizer Receives CRL for Biosimilar to Roche’s Herceptin

On April 23, 2018, Pfizer announced that it received a complete response letter (CRL) from FDA in response to the biologics license application (BLA) for the company’s proposed trastuzumab biosimilar, which references Roche’s Herceptin (trastuzumab). Trastuzumab made approximately US$7 million in 2017 sales.

In the CRL, FDA emphasized the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer states it is working with FDA to address the contents of the letter.

The agency also issued CRLs to Celltrion for the BLAs for CT-P10 (rituximab), a proposed biosimilar to Roche’s Rituxan/MabThera (rituximab), and CT-P6 (trastuzumab), a proposed biosimilar to Roche’s Herceptin (trastuzumab) in early April 2018. The CRLs stem from a warning letter that FDA issued to Celltrion on Jan. 26, 2018 after an inspection carried out from May 22 to June 2, 2017 at Celltrion’s drug manufacturing facility in Incheon, South Korea. The letter raised issues related to certain manufacturing process at the facility.

Newcells 3 June 2024, 15:12
Novonordisk: Wed 17 July 2024, 11:22
FujiFilm 30 October 2023, 16:23
Autoscribe Mon 26 June 2023, 15:15
Aldevron: 16th January 2025
Richter: Wed 23 October 2024, 09:03
GenXPro: Mon 16 September 2024, 10:40