Recent Legislation a Boost for Biosimilars?

Biosimilars, also known as “follow on biologics,” are copies of currently marketed biopharmaceuticals. After a biopharmaceutical’s patent protection and exclusivity has expired, other companies can copy the original product, also called “innovator products”. The goal of the biosimilar industry is to provide a similar product to the original and to make these products available at a reduced cost, a strategy successfully used with generics. The difference is that generics are exact copies of small molecule drugs that can be analyzed to verify that they are exact. Biopharmaceutical drugs are much more complex and difficult to manufacture, so there is no way to make an exact copy, only a similar.

Critics say that because biopharmaceuticals are highly complex, they are sensitive to the slightest changes in manufacturing. They have concerns that biosimilars will not perform the same in humans, thus compromising safety. Unlike generics, there is no way to analyze what these differences may mean once administered to a patient. Due to these concerns, critics argue that there must be full clinical trials for these drugs to ensure patient safety. To add further challenges, there has been some difficulty gaining physician acceptance in Europe. There is also the question of patient acceptance. In our current internet powered environment, patients Google the drugs they are prescribed and pharmaceutical companies spend billions of dollars every year on advertising to be sure patients know their drugs by name. The question remains whether patients and physicians will accept drugs that are similar but not exact.

Supporters of biosimilars argue that biosimilars can provide a significant cost savings over existing biopharmaceuticals. For example, Omnitrope, a biosimilar human growth hormone that was approved in Europe in 2006, is offered at a 25% price reduction. Biosimilar companies also have the advantage of improved technologies including production systems that are more advanced, more cost-effective and more defined than systems being used when the innovator products were approved. Providing additional support are leading pharmaceutical companies, such as Merck and Pfizer, who are now entering the market with biosimilar products.

Recent legislation has also supported biosimilars. On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (PPACA) and for the first time clearly outlined a regulatory pathway for approval of biosimilars in the United States. In the PPACA, it states that once a biosimilar has been approved it can be substituted for the innovator product because they are effectively interchangeable. There is also a provision that provides exclusivity for the first biosimilar product that is deemed interchangeable with the innovator product. These are very important developments for biosimilars because they define a pathway for approval and provide protection in the form of exclusivity, which is critical for companies investing hundreds of millions of dollars to create biosimilars.

Some have argued that because biosimilar companies have access to better technology than existed when the innovator products were approved, that they can create a better product. Certainly they can utilize manufacturing systems that are completely animal-free and defined, which would be an improvement over some innovator products that are manufactured utilizing animal or other undefined components.

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