FDA Briefing Document Oncologic Drugs Advisory Committee Meeting July 13, 2017 BLA 761074 MYL-1401O, a proposed biosimilar to Herceptin (trastuzumab) Applicant: Mylan Pharmaceuticals
FDA Briefing document conclusion : `In considering the totality of the evidence and the established scientific bridge between EUHerceptin,MYL-1401O, and US-Herceptin, the data submitted by the Applicant show that MYL-1401O is highly similar to US-Herceptin, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between MYL-1401O and US-Herceptin in terms of the safety, purity, and potency of the product.
Regarding Manufacturing Process: ` The data provided demonstrated that the MYL-1401O drug substance manufacturing process sufficiently reduces the impurities to very low levels (e.g., ppm for HCP and pg/ml for HCD)
Have brought this from BIOCON Board, MMB where I am a regular. Posted by a fellow boarder.