Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are highly similar to existing biological products and are designed to be as effective and safe as the brand name drugs, offer the potential to provide
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab). We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The
Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars. During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.
According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled
Introduction
The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products. By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept