What Are Biosimilar Drugs?
The FDA Has Launched a New Process for Approval of Biosimilars
Biosimilars, sometimes referred to as biogenerics, are highly similar versions of biologics – medicines that are made from living microorganisms found in plant or animal cells. The term “generic” refers only to traditional or small molecule drugs that are bioequivalent to an already approved small molecule drug.
What Are Biologics?
Most biologics are very large, complex molecules or mixtures of molecules, used to treat cancer, Alzheimer's disease, multiple sclerosis, HIV/AIDS and other serious diseases.
Biologics Price Competition and Innovation Act
Approval of biosimilars can help save costs. Treatment with biologic drugs can cost patients and insurance companies anywhere from $100,000 to $300,000 a year. The Generic Pharmaceutical Association (GPhA) says evidence from several studies suggests that an increased entry of biosimilars into the market could save $42 billion to $108 billion over a 10-year period.
President Obama signed the Patient Protection and Affordable Care Act into law in 2010, and an abbreviated pathway to approval for biosimilars was approved as part of that legislation. Under the Biologics Price Competition and Innovation Act (BPCIA), a biological product can be determined to be biosimilar if data shows that it is very similar to an already approved biologic medication.
A biosimilar product must have comparable levels of efficacy and safety to the original product to be approved on an accelerated timeline; the only differences allowed are in non-active ingredients or components.
The First Biosimilars Approved
The FDA approved the first biosimilar product in the United States in March of 2015: Zarxio. Zarxio was a biosimilar to Neupogen, a medication indicated for the treatment of patients:
- With cancer receiving myelosuppressive chemotherapy
- With acute myeloid leukemia receiving induction or consolidation chemotherapy
- With cancer undergoing bone marrow transplantation
- Undergoing autologous peripheral blood progenitor cell collection and therapy
- With severe chronic neutropenia.
Impact on the Industry
Biosimilar products are suspected to continue to have a significant impact on the pharmaceutical industry in the U.S. and in Europe. Due to increased competition with the accelerated approvals of biosimilars and their rapid introduction to the marketplace, market conditions will have to evolve to adapt. Not only will patients have more treatment options, but they will also potentially have the ability to get the medications they need for serious disorders at much lower costs than the original biologics. With biosimilars becoming more widely available, consumers can expect the same efficacy, safety and reliability as the original medication at a reduced price.
The FDA's approval of an accelerated timeline for biosimilars signals a change in the industry and potential for severe drops in profits for pharmaceutical companies. This is an opportunity for organizations specializing in generics and biosimilars to grow their businesses rapidly.
Companies like Coherus, Teva and Sandoz are expected to show a great deal of growth over the next decade as they bring more biosimilar products to market.
This is a market that will remain in focus in this billion-dollar industry with the possibility of changing the industry forever.