Biosimilars Backgrounder
Contents
- Biologics developed by America’s biopharmaceutical companies have made significant contributions to the health of Americans.
- Because of the scientific complexity of biologic products, there is no such thing as “generic biologics.”
- Any regulatory approval pathway for biosimilar products must protect patient safety.
- Given current science, interchangeability of a biosimilar product for a previously approved biologic should not be permitted.
- Any regulatory pathway for the approval of biosimilar products must reward investment in biopharmaceutical research and encourage future innovation.
Biologics developed by America’s biopharmaceutical companies have made significant contributions to the health of Americans.
In addition to the many hundreds of innovative small molecule drugs developed by America’s biopharmaceutical companies, many biologics have been approved by the Food and Drug Administration to treat cancer, rheumatoid arthritis, multiple sclerosis, and numerous other diseases. There are more than 600 new biologics currently in development to treat more than 100 diseases. Biologics are large, complex molecules (10-100 times as large as a typical small molecule drug) derived from living cells or organisms. Their complexity is what makes them powerful medicines against many human diseases.
Because of the scientific complexity of biologic products, there is no such thing as “generic biologics.”
In order to earn approval from the Food and Drug Administration, a generic manufacturer of a small molecule drug must prove that the generic drug is the same as the original drug, but clinical trials are not required to demonstrate safety and efficacy. However, biologics, which are derived from living organisms, are far more complex than small molecule drugs. Biologics, made by different, unrelated manufacturers will not be the same. Therefore, it would be impossible to guarantee that a new biologic product is the same as an existing biologic. Rather, the new product would likely be at most “biosimilar” to an existing, approved biologic product.
Any regulatory approval pathway for biosimilar products must protect patient safety.
Prior to approval of any new medicine, whether a small molecule or biologic product, America’s biopharmaceutical companies put their products through three phases of clinical trials, typically lasting six or more years with thousands of patients participating. These trials ensure that the drug under development is effective in fighting disease and safe for use in its intended patient population. Companies also continue testing and safety monitoring once a product is on the market, allowing for identification of adverse effects as more and more patients use the product.
Generic small molecule drugs are not required to conduct clinical trials because they are deemed to be the same as the original product. But because it is impossible to demonstrate that biologic products derived from different, unrelated manufacturers are identical, any legislation establishing a regulatory approval pathway for biosimilars should require clinical trials to demonstrate that the follow-on product is safe and effective.
Given current science, interchangeability of a biosimilar product for a previously approved biologic should not be permitted.
The differences between biologics made by different, unrelated manufacturers may affect how they work in patients. Currently, there is no scientific consensus on how to establish safe interchangeability for products that are similar and not the same. To avoid potential safety and efficacy problems, physicians need to know that the product they prescribe to a patient is the product the patient will receive.
Physicians also must be able to distinguish between products so that any adverse events can be attributed to the right product. This can be achieved by requiring that a follow-on product is given a different name from the innovator product.
Any regulatory pathway for the approval of biosimilar products must reward investment in biopharmaceutical research and encourage future innovation.
Both patents and data exclusivity are important forms of intellectual property protection that support innovation. In the context of biosimilars, patent protections for biologics are less certain than traditional small molecule drugs. Biosimilar manufacturers may be able to get around patents while relying on the innovator company’s data for FDA approval. Therefore, data exclusivity provides important certainty for investment in R&D. Economic analysis indicates that the data exclusivity period for biologics should be at least 14 years. Several factors support this period including: the high cost and time required to build specialized facilities; the higher costs of capital and dependence on venture capital; and, the research and development that continues after the initial approval of a biologic which may lead to medical advances even in very different disease areas.
America’s biopharmaceutical research companies support the establishment of a science-based, Biosimilars regulatory approval pathway with substantial incentives for innovation that ensures patient safety and does not reduce incentives for the development of future medicines.