The phase 3 study of Amgen Inc. and Allergan Plc's biosimilar candidate ABP 215 reached a significant milestone. The study, which looked into its safety and efficacy, yielded promising results that made it at par with Roche Holding AG's Avastin, a cancer drug proven to decrease lung cancer procession and increase survival rate.
In 2014, Roche's Avastin reported a staggering $6.5 billion in sales. The trade of Roche's lung cancer drug paved the way for the arrival of copycats called 'biosimilars'.
In March 2015, the United States' Food and Drug Administration (FDA) approved the very first biosimilar lung cancer drug called Zarxio. Manufactured by Novartis AG, Zarxio boosts the efficiency of white blood cells. Reports said Amgen Inc. was the biosimilar's original owner. The company failed to stop Zarxio's launch early in 2015 despite several lawsuits.
"Amgen is committed to bringing high-quality, reliably supplied medicines to patients and we're excited to leverage our development and manufacturing capabilities in oncology for our biosimilars," said Dr. Sean E. Harper, Amgen's executive vice president of Research and Development.
Allergan's president of Global Research and Development David Nicholson added that ABP 215's successful clinical results is a crucial step in the development of other biosimilars for advanced non-small cell lung cancer (NSCLC) patients. Nicholson is also Allergen's executive vice president. He stressed the drug company's pledge to produce effective treatment in key disease areas.
The two drug companies are in collaboration to produce four other biosimilars, the first of which is ABP 215. Upon receiving FDA approval, ABP 215 will be their very first biosimilar drug in the market. It will compete head-to-head with Novartis' Zarxio and Roche's Avastin. Independently, Amgen is working on eight more biosimilars. Allergan also has independent biosimilars in their developmental stages.
The medical community will definitely benefit from the production of biosimilars. They do, however, pose continuous threats to companies such as Roche.
NSCLC is ranked the top cause of cancer deaths in both European Union (EU) and United States (US). In 2006, EU reported 265,600 new cases of NSCLC and 236,000 NSCLC-related deaths. The numbers are just as bad in the U.S. In 2012, 226,160 new cases and 160,340 deaths were reported.