Sandoz announced Monday that its version of Amgen's NEUPOGEN proved to be highly similar to the original in preventing severe neutropenia in individuals with breast cancer being treated with neoadjuvant myelosuppressive chemotherapy. Neutropenia is a condition where the body has an excessively low number of white blood cells.
The Novartis company's claims are backed by data from the Phase III study it carried out to compare safety and efficacy between the biosimilar it is developing and NEUPOGEN. Called PIONEER, the Phase III trial involved a randomized, multi-center, four-group, double-blind, non-inferiority study administered to 218 patients with breast cancer in 27 centers.
The U.S. Food and Drug Administration had accepted Sandoz's filgrastim application in July, making the company the first to have an accepted filing under the Biologics Price Competition and Innovation Act of 2009. This filing supported the results the PIONEER study yielded.
According to Professor Kimberly Blackwell from the Duke University School of Medicine, biosimilars have the potential to play important roles in widening access to top-quality biologics in the U.S. Since biosimilars are more affordable than the originals they are copying, savings will be generated which can then be used to finance other medical needs.
"We are pleased by these clinical study results as they confirm the similarity of our investigational biosimilar filgrastim compared to the reference product in terms of safety and efficacy," said Mark McCamish, M.D., Ph.D., Sandoz's Global Biopharmaceutical & Oncology Injectables Development head, adding that the company is excited about the prospect of making the product available in the U.S. to healthcare providers and patients.
With a share of more than 50 percent of biosimilars that are approved in Australia, Japan, Europe and North America, Sandoz is a global leader in the segment. Outside the U.S. the company is marketing three biosimilars at the moment, each one of which are ranked first in their respective categories. Biosimilars from Sandoz are available in more than 60 countries, generating an experience of more than 170 million days of patient-exposure. The company also has six molecules along its pipeline, all under Phase III trials or in the process of being registered. That number is more than what any other company has in store in any industry.
The biosimilar that Sandoz intends to distribute in the U.S. is already available in over 40 other countries. By the end of the decade, it is expected that biosimilars will account for around a quarter of the $100-billion sales generated by off-patent biological drugs.
