In the world of drug production, the search is relentless for treatments that can reduce the planet’s spiralling pharmaceutical bill by curing illness.
However, although billions of pounds is ploughed into developing new drugs, attention is increasingly focusing on making more use of what we already have in the form of the emerging ‘biosimilars’ market. Biosimilars, which are biological products that are ‘highly similar’ to licensed biological products apart from minor differences, are attractive to manufacturers because of the commercial opportunities and, with the promise of more choice for patients and cost-savings for health services, they are also interesting governments. Biological products, on which biosimilars are based, are defined as products that are made using human or animal materials and include vaccines, blood, blood components, allergenics, somatic cells, gene therapy, tissues, and proteins.
According to the US Food and Drug Administration (FDA), one of the regulatory bodies wrestling with the issues presented by biosimilars, distinctions should be drawn between biosimilar and generic treatments. The FDA says that generic refers to small-molecule drugs that are deemed bioequivalent to an existing drug but to be deemed ‘biosimilar’ the product has to be ‘interchangeable’ with the already-approved version and produce the same clinical result. According to those who champion the industry, the benefits of supporting biosimilars include an increase in patient access to treatments because more companies are being drawn into the industry. One reason for that trend is the upcoming expiration of patents owned by some drug companies, which is effectively opening up the market.
The increase in manufacturers becoming involved not only allows more products to be available but also drives down costs for those prepared to invest, not least because a significant amount of the research has already been done. The promise of reduced costs is a key reason why regulatory bodies are working so hard to support the market; they can see that the availability of cheaper drugs offers potential savings for healthcare services at a time when spending on pharmaceuticals is rocketing. One estimate for the United States alone estimates that biosimilars could save the US Government $25 billion over the next ten years and it is the same story in other parts of the world. However, there are challenges for biosimilar manufacturers, including the fact that they are obliged to notify the company they will be directly competing against that they are developing a similar drug to the original biologic.
Another challenge is the need to prove that the drugs are safe even though they are closeely related to existing products. The FDA in the United States, for example, has set up a system in which biosimilar manufacturers need to test and validate their drugs “to ensure the quality, safety and efficacy of a biologic.” Such requirements are also in operation in Europe for drug manufacturers. Despite the challenges, biosimilars could prove to be a significant part of the pharmaceutical market in the near future; an IMS Health report released in December 2011 predicted that by 2020, the US biosimilar market alone may be as large as $25 billion. Similar growth is expected elsewhere, including Europe. As the sector grows, the United States is among countries witnessing a lot of support for biosimilar development.
The first biosimilar approved under the new FDA regulations was ZarxioTM (filgrastim-sndz) from Sandoz, which gained clearance in March. Sandoz, a Novartis company, was given clearance for the cancer therapy drug after analysis of non-clinical, and clinical data assured regulators that it met the biosimilar criteria. The drug treats people with neutropenia, who have an unusually low number of neutrophils, a type of white blood cell in the immune system that helps the body fight infection. People who have neutropenia are at increased risk for developing serious infections and it occurs in about half of people with cancer who are receiving chemotherapy. It is a common side effect in people with leukemia. The decision to grant it approval delighted Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz, who said: “FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia.”
Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University, said: “Biosimilars have the potential to increase access and the approval of Zarxio may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice.” Among other companies spending big is Oncobiologics, Inc., a biotherapeutics company that develops monoclonal antibody (mAb) biosimilars, which recently completed the construction of a new manufacturing facility at its headquarters in Cranbury, New Jersey.