- Roche's Avastin (bevacizumab), which grossed roughly $6.5 billion last year, is approved for several different types of cancer, including non-small cell lung cancer (NSCLC).
- The first biosimilar approved in the U.S. (fligrastim-sndz) is a biosimilar version of Amgen's Neupogen.
- Despite the fact that Amgen worked hard to prevent Zarxios entry into the market, it is also active in biosimilar development, with a total of eight biosimilar drugs in its pipeline.
When Zarxio was approved in March, Amgen made it known that it too had biosimilar aspirations, and now it seems that at least one of its drug is getting closer to approval. Amgen and Allergan made an announcement this week that their biosimilar version of Avastin, known as ABP 215, has shown similar efficacy to Avastin for treatment of NSCLC in late-stage clinical trials.
Looking back to the pivotal trials that led to the approval of Avastin for NSCLC in October 2006, clinical trials showed that Avastin used as adjuvant first-lline treatment in patients with NSCLC increased overall survival, compared with standard-of-care (OS=12.3 months vs. 10.3 months, P=0.013). It shoudl be noted that althogh Avastin is a $6.5 billion-per-year drug in terms of revenues, it is indicated for various types of cancer. In addition to NSCLS, Avastin is also indicated for use in patients with colon cancer, ovarian cancer, cervical cancer, metastatic kidney cancer and recurrent glioblastoma.
Amgen and Allergan are currently focusing on NSCLC, but will most likely go after the other Avastin indications as well. However, even if it is approved, ABP 215 will most likely not take a large percentage of the Avastin market right away, given the fact that Avastin is so well entrenched. What will be most interesting to many onlookers will be the level of discount that the marketing partners extend to payers upon approval.