Research & Development
Biologics & Biosimilars
What are Biologics and Biosimilars?
Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines. Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.
A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA).
Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure.
In 2010, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars while maintaining 12 years of data protection to incentivize the development of new innovative biologics. This framework has provided more options for patients, increased access to lifesaving medications, and lowered health care costs through additional competition in the marketplace.
Supporting a Robust Biosimilars Market in the U.S.
To foster a robust biosimilar market, we believe the following steps should be taken:
- Ensure the long-term stability of the Biosimilar User Fee Act (BsUFA) program through financial transparency, efficiency, and accountability
- Increase focus on provider and patient education including the development and dissemination of evidence-based materials on the full range of treatment options, including biosimilars.
- Address barriers to appropriately structured alternative payment models, particularly in Medicare, that have the ability to increase competition among innovator and biosimilar products.
- Advance meaningful rebate reform that would remove barriers to biosimilar uptake and promote access and competition.
- Increase transparency for patents on biologic products consistent with what is currently available in the FDA Orange Book for drug products. Policies that relate to listing patents for biologics should encourage competition without creating an undue burden or risk, requiring overbroad listings that could mislead the public, or improperly disclosing protected trade secrets.