Estimates for biosimilar approval in the United States range anywhere from two to five years, but that may only be the start of some considerable challenges for US drug makers.
The global market for oncology biosimilars is expected to boom over the next few years and predictions have that market alone generating between $6 and $12 billion by 2020. A recent IMS report predicts the US will have a direct impact on the global reach of these products and this potentially lucrative business. Explains the author of the report, “The US is the largest biologic market by size, and is pivotal to the success of the overall biosimilar market.”
But if the U.S. is to become the factor everyone expects, it will not be without overcoming their share of obstacles. The report found the US to be trailing the rest of the world in biosimilar development primarily due to a complex regulatory process.
Said Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit, in a recent interview with Specialty Pharma Times:
“One of the most important roadblocks is clarity in the regulatory pathways. The pathways are evolving all the time, and this is especially true in the biosimilar world. The current regulation doesn’t provide the needed clarity for specific molecules. One of the most challenging parts is when we submit drug submission packages with the best analysis finding the best chance for being approved, sometimes we struggle in identifying what exactly are going to be the demands of the regulatory agencies because the current regulations have many grey areas that need to be clarified case by case.”
Among other obstacles are the struggle in proving a biosimilar is the same product as the name brand. Not only is it difficult to prove that a biosimilar is the same product as a name brand, but the process of proving that similarity is not well defined.
Coindreau cited another reason that’s overlooked by many. Difficulty in recruiting patients for clinical trials is an obstacle not just for US drug makers, but for global companies as well. He discussed the idea that patients would be more apt to enter a trial for a new treatment as opposed to one that is supposedly the same. “They think if I’m going to enter a trial, I’m going to do it for a new molecule not something that’s the same as the previous one,” he said.
Whether the approval for biosimilars in the US is two years from now or five years, there’ll be a host of challenges for drug companies. We’ll have more on those challenges at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.
SAVE $100. Register here and use code XP1986BLOG.
Join us on LinkedIn
Share this article with your social network, just click below to share now!