The Affordable Care Act was approved in 2010 with the goal of reducing healthcare costs. The Act’s main function was to clear the way for the Food and Drug Administration (FDA) to create an approval process for biogenerics. Since passage of the Act, the FDA has been working on guidance that would outline the biogenerics regulatory pathway and specific steps needed for approval. There was talk from the FDA that guidelines would be issued prior to the end of 2011. On December 16^th, the FDA held a meeting to discuss proposals for a biogenerics user fee, but still no guidelines have been published.

Despite delays from the FDA on the regulatory approval process, biogenerics are one of the fastest growing areas of product development in biopharmaceuticals. Amgen, Biogen Idec, and Baxter are the latest in a growing list of pharmaceutical companies investing in biogenerics. In a recent article in Genetic Engineering News titled, “Firms are Upping the Stakes on mAb Biosimilar Development,” Rituxan (a Genentech biologic prescribed for non-Hodgkin’s Lymphoma and Rheumatoid Arthritis) is described as an example of a target drug for many biogeneric companies. Rituxan had revenues of 6.6 billion in 2010 and is set to come off patent in 2015. Spectrum, Teva, Celltrion, and Sandoz (Novartis’ biogenerics arm) are all working on a biogeneric version of Rituxin. Rituxin is just one example of more than 30 branded biologics with a total of $51 billion in revenue that are set to come off patent between 2011-2015.

Earlier this month, Amgen signed a deal with Watson to develop biogenerics for oncology. Also in December, Baxter signed a deal with Momenta and Biogen Idec signed with Samsung, all with the goal of developing a line of biogeneric products. These three are just the latest in a long list of pharmaceutical companies who have decided to invest in this growing market. In a previous blog on The Cell Culture Dish titled “Can Biogenerics Deliver on the Multi-billion Dollar Market Promise?” I outlined the increasing number of pharmaceutical companies partnering to bring biogenerics to market. With the estimate for getting a biogeneric to market at 100 million dollars and five or more years, it makes sense that many biogeneric companies need the financial support, regulatory experience, and manufacturing expertise that large drug companies have. In addition, these biogenerics will need to have a final product cost that is less expensive than the original biopharmaceutical. With respect to cost, biogeneric companies have the advantage of improved technologies, including production systems that are more advanced, more cost effective, and more defined than the original systems. They can utilize manufacturing systems that are completely animal-free and defined, which would be an improvement over original products still manufactured using animal or other undefined components.

Another big challenge for pharmaceutical companies who have both original biologics and are now working on biogenerics is how to maintain a position on both sides of the biologics debate. Amgen, for example, has the original biologics Epogen and Neupogen coming off patent in 2013 and they will want to promote the use of their original products over biogeneric competitors. Many believe that this will be a difficult position to maintain since they will also be promoting oncology biogenerics that are manufactured as a result of their partnership with Watson. It will also be a challenge with regulators. Will they fight for extended patent protection and stricter regulations for biogenerics as many innovators like Genentech have done, or will they advocate toward a more favorable approach to biogenerics opening their product to new competitors?

The biggest question of all still remains; when will the FDA issue its guidance for biogeneric approval and what will be required by FDA to show bioequivalence?

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