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European Commission approves biosimilar bevacizumab

The European Commission (EC) has granted marketing authorisation for a biosimilar bevacizumab.

This biosimilar bevacizumab is approved for the treatment of certain types of cancers including:

  • in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer
  • in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent nonsquamous non-small cell lung cancer (NSCLC)
  • in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC
  • in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer
  • in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix

The European Commission’s approval of his this biosimilar bevacizumab "marks a significant milestone for both Amgen and the oncology community, providing a biosimilar for a medicine which is used across multiple types of cancer,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

This biosimilar bevacizumab "is the first targeted cancer biosimilar from Amgen’s portfolio approved in Europe, underscoring our commitment to delivering high-quality medicines that address some of the most serious illnesses.”

Amgen and Allergan are committed to developing high-quality biosimilars with a robust analytic and clinical package.

The EC approved this biosimilar bevacizumab based on a comprehensive data package that demonstrated this biosimilar bevacizumab and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products.

Clinical studies included results from a Phase 3 trial in patients with non-squamous NSCLC.

This biosimilar bevacizumab "is the first product from our collaboration with Amgen to receive marketing authorisation from the European Commission, highlighting the success of our joint commitment to developing cancer biosimilars," said David Nicholson, chief research and development officer at Allergan.

“We look forward to our continued work with Amgen and to providing important medicines to patients in the future.”

Source: Amgen



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Cancer Intelligence