It should be the discretion of individual physicians, not insurance companies or pharmacies, to substitute a branded biologic for a biosimilar, which goes back to putting the physician in the decision making process, not the non clinical analyzers. While the search for "cheap" continues we will all be taking products with Asian or Indian technologies soon, and not American.
There are still quite a few biotech companies that go "bust" as well, so there's not always a guarantee until the clinical results are in, and with the use of genomics and smaller focus groups, this process has been sped considerably compared to how it was done in the past. Candidates can be better defined even before participation begins.
This is one delicate situation here, do we want to be the leaders and create our own solutions or end up being consumers of what is developed "cheaper" in other nations? Big question, but then there also comes the balance of funding from grants and venture capitalists as well. Private funding has made great strides available where grants are either not available or too complicated to qualify and secure.
Thank goodness someone is making the effort to explain genomics to Congress, and and I hope they can grasp the concept instead of relying on the "cheap" business model that has been driving healthcare decisions for a very long time, and yes we need a happy medium along the line as well. Robbing Peter to pay Paul went out years ago when it comes to biosimilars, so if not allowed, the higher priced brand names become unreachable for many. Many create their own generics to compete as well as a way of lower costs, but still maintaining a cost recoverable amount of the market share. BD
Geoffrey Allan has been giving Congress a lesson in biotechnology. He's explained protein structures and how they work. He's reviewed how drugs are absorbed into the body.
"We've always supported a pathway," said Genentech spokeswoman Megan Pace. "We just want to make sure patient safety and data protection for innovators will be a part of the bill."
Because biosimilars aren't exact duplicates of the original drugs, they don't violate the original drug's patent, enabling legal distribution before patent expiration. As a result, the Biotechnology Industry Organization, as well as the handful of biotechs that control most of the market, supports a 14-year period to allow companies to recoup their investment and conduct further clinical trials to improve the product.
But the potential market is big. Four of the six FDA-approved drugs for multiple sclerosis are biologics. Treatment can cost a patient more than $30,000 a year, prohibiting many from obtaining drugs, said Shawn O'Neail, an associate vice president at the National MS Society.
Biotech Campaigns for Easier Access to Generic Drug Market - washingtonpost.com
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