Amgen/Allergan and Pfizer Present Positive Phase 3 Data For Two Investigational Trastuzumab Biosimilars

Goodwin
Contact

At the European Society for Medical Oncology (“ESMO”)  2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab).

First, Amgen presented Phase 3 study data on ABP980, which it is co-developing with Allergan plc, comparing the safety and efficacy of ABP 980 to Herceptin in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Amgen reported that the efficacy, safety, and immunogenicity data supports ABP 980 as a trastuzumab biosimilar.

Second, Pfizer presented Phase 3 study data on PF-05280014, its investigational trastuzumab biosimilar.  Pfizer’s Phase 3 REFLECTIONS B327-02 study found no clinically meaningful differences between PF-05280014 and Herceptin in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics in patients with HER2-positive breast cancer.

As we previously reported, other companies are engaged in Phase 3 clinical development of proposed biosimilars of Herceptin, including  Samsung Bioepis (SB3), Mylan/Biocon (MYL-1401O) and Celltrion (CT-P6), the latter two of which have already submitted aBLAs to the FDA (as reported here and here).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide