Biosimilars: Different, but similar?

Biosimilars are different from what are commonly known as biomedicals or biologics. Biosimilars are competing biomedical drugs that are similar but not exact copies of the complex and expensive biologic drugs. Biosimilars are sometimes referred to as generics but this is not accurate. Whereas non-biologic drugs can be replicated down to the molecular level, biologics are unique and another manufacturer can never make the exact same drug. The production of biosimilars differs early, from a new manufacturing process that does not begin from the exact same biologic materials. Biosimilars allow the therapies to come to market cheaper and therefore be available for a wider range of consumers. For many, this seems like a great thing, but there are other sides of the issue to understand as well.

The original makers of the drugs and treatments stand to lose the most from biosimilars, as they have already invested extensive research hours and dollars into producing their brand name biologics, which they seek to protect. When producers of biosimilars are able to begin production of their drugs after short development periods and sell the drugs at a lower cost, they turn higher profits almost immediately. The original manufacturers that spent the money and years on development are forced to sell at a high price to recoup the costs, but are continually undercut by the biosimilar producers.

Protecting the original innovators is not as easy as a patent, however. Non-biological drugs are often protected by one or more patents. In the case of biomedical drugs, the protection granted by a patent may not be enough. As previously mentioned, biomedicals are complex drugs. This provides the opportunity for competitors to analyze how the original drugs work and produce copycat versions that are effectively similar but different enough to avoid violating patent rules. Biomedical drugs are fundamentally different from non-biologic drugs, and require different standards of protection.

In addition to having the same active ingredient(s), strength, dosage form, and administration as the original drug, to be approved as a generic a drug also needs to be "bioequivalent." Bioequivalency requires the generic drugs to be chemically similar to original drugs so that they behave in the same way when in the patient’s body. When the generic is approved by the FDA as being bioequivalent, it effectively means that the two drugs are interchangeable. However, in the case of biologic therapies, the FDA has not determined a way to establish interchangability and bioequivalence due to the complex structures. When biosimilar manufacturers establish new manufacturing processes and begin with new starting materials, the product will not be therapeutically equivalent to the original. Many in the biotechnology community have indicated that clinical trials are the best way to establish whether there are differences that affect the safety and effectiveness of the follow-on product because of their complexity.

Patient Concerns

On the other side of the issue are patients. Biomedicals are as expensive as they are complex. When patients cannot afford them, the drugs are not serving their purpose. When biosimilars are made, they give more patients access to the treatments. Patient advocacy groups are often proponents of laws that give these biosimilar producers access to the development process early.

Recently, the passage of the Patient Protection and Affordable Care Act – more commonly called the Healthcare Reform Act – authorized the FDA to grant biologics manufacturers 12 years of exclusive use before generics can be developed and approved. While this can seem like a very long period of time to protect the makers of biomedicals, if they are immediately continuously undercut by biosimilar manufacturers, they will not be able to spend the time, research power, and money to develop other therapies in the future.

Researchers at Duke University have found that for developers to break even and cover the development, manufacturing and sales costs, it takes 12.9 to 16.2 years. While the twelve year period of data exclusivity granted by the act is close, those final months are years are crucial for the developers and could likely lead to lost investments and a future loss of innovation.