In March 2010, when President Obama signed into law the Affordable Care Act he cleared the way for the Food and Drug Administration (FDA) to approve biogenerics. Before this there was no pathway for a biogeneric approval because biopharmaceuticals were just emerging and were not included in the 1984 Hatch-Waxman Act, which allowed for generic versions of chemical drugs. Since the passage of the Affordable Care Act, the FDA has begun working on guidance for the biogenerics regulatory pathway and approval process. Unlike the process for approval of a generic chemical drug, the FDA has stated that the approval process will include clinical trials.
The reason for the addition of clinical trials is most likely due to the difficulty of manufacturing and complex nature of biopharmaceuticals. It is impossible to produce an exact copy of biopharmaceuticals, so manufacturers of biogenerics will attempt to make a similar product with the same function.
The goal the Affordable Care Act is to reduce the costs of biopharmaceuticals, which are very effective, but also very expensive for consumers. According to the Chicago Tribune, Abbott’s biopharmaceutical Humira, used for treatment of autoimmune disorders such as rheumatoid arthritis, Crohn’s Disease, and Psoriasis, costs on average $20,000 per patient, per year. The anti-anemia biopharmaceutical Epogen costs about $10,000 per patient, per year. With the high cost of these drugs there is an opportunity for companies to capitalize and produce a biogeneric at a reduced price. Hospira, a pharmaceutical company, is already selling a generic Epogen in Europe and started clinical trials in the United States last year, presumably in preparation for FDA approval. Also in Europe, Omnitrope, a biogeneric human growth hormone, is offered at a 25% price reduction in comparison to the original product.
One of the most important considerations for companies interested in producing biogenerics is when the original product’s patent expires. For instance, the patents for Humira don’t start to expire for five years, so companies will have to wait a minimum of five years before Humira would be eligible for a biogeneric version. However, many other successful biopharmaceutical patents will be expiring within a few years. These will certainly be targets for biogeneric companies, but it is unclear what the actual cost savings will be after adding in the cost for process development, manufacturing and regulatory approval, including clinical trials, which are quite pricey. It is also uncertain the extent and number of clinical trials that will be required for FDA approval.
When it comes to cost reduction, Biogeneric companies have the advantage of improved technologies, including production systems that are more advanced, more cost-effective, and more defined than systems being used originally. They can utilize manufacturing systems that are completely animal-free and defined, which would be an improvement over some original products that are still manufactured using animal or other undefined components.
When will biogenerics be available in the United States? It all depends on FDA requirements for approval and how quickly biogenerics can meet them. Certainly, with so many blockbuster biopharmaceuticals on the market, once the first biogeneric is approved there will be many others who will attempt to follow in their footsteps.