Global Biosimilars Approval and Launch Updates

Goodwin
Contact

Goodwin

Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA).  This same product was approved by the European Commission on July 27th.  According to the press release, this is the the first China-developed mAb biosimilar to be approved both in China and in the EU.  Trastuzamab is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

Sandoz Canada Inc. announced on August 19, 2020 that it reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) and launched ZIEXTENZO  (pegfilgrastim) and RIXIMYO (rituximab) in Canadian hospitals and pharmacies. This follows the recent approval of the two biosimilars by Health Canada.  ZIEXTENZO is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic agents. RIXIMYO is approved for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as the autoimmune disease rheumatoid arthritis (RA).

Samsung Bioepis Co., Ltd. announced yesterday that the European Commission (EC) granted marketing authorization for  AYBINTIO (bevacizumab) for the treatment of metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer.  AYBINTIO is Samsung Bioepis’s fifth biosimilar approved for use in Europe.

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

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.