When was BPCIA passed?
March 2010
In March 2010, Congress passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This law established a statutory pathway for approval of “biosimilars,” follow-on versions of innovative biological products.
What is the name of the statue that provided for abbreviated approval of biologics?
The FDA administers the FFDCA and PHSA (among other statues). FFDCA applies to all drugs and medical devices, and PHSA applies to “biological products.” Marketing approval under the FFDCA is by means of a New Drug Application (NDA) while approval under the PHSA is by means of a Biologics License Application (BLA).
How many years of marketing exclusivity accrues to an interchangeable biosimilar under the BPCIA?
12 years
The BPCIA provides reference biologics with 12 years of data exclusivity regardless of patent protection; no biosimilar can be approved through the BPCIA until 12 years after the reference biologic was approved.
How Biosimilarity for biologics is determined?
Whether the follow-on biologic is biosimilar is determined using three sources of data: “analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” “animal studies (including the assessment of toxicity) …
What are biologics used for?
What are the medical uses for biologics? Biologic drugs are used for treatment of numerous diseases and conditions, and are the most advanced therapies available. Some biologic drugs are used for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.
What is the patent dance?
The BPCIA framework for addressing patent infringement concerns has often been called the “patent dance.” In this dance, the biosimilar applicant takes the lead and ultimately dictates the scope of a first patent litigation.
How many biologics are approved in the US?
The 53 approvals in 2020 are divided between 40 new chemical entities and 13 biologic drugs (biologics).
Are hormones biologics?
Note that hormones such as insulin, glucagon, and human growth hormone are regulated as drugs under the FDC Act, not biological products under the PHS Act.
What is a biosimilar agent?
A biosimilar is a biological product FDA-approved biosimilars have been compared to an FDA-approved biologic, known as the reference product.
What’s the difference between biologics and biosimilars?
Biologic drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Unlike generic drugs, which are copies of chemical drugs, a biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine.
Are biosimilars safer than biologics?
Biosimilars are as safe and effective as the original biologic; both are rigorously and thoroughly evaluated by the FDA before approval. Before approving a biosimilar, FDA experts must conclude it is highly similar to and has no clinically meaningful differences from the original biologic.
