Ever since the Biologics and Price Competition and Innovation Act (BPCIA) of 2009 found its way into the Affordable Care Act, various stakeholders have been preparing for the U.S. introduction of these so-called “biosimilars.”
Novartis/Sandoz announced in July 2014 that EP2006 was the first 351(k) application accepted for review by US Food and Drug Administration (FDA), an event that occurred almost four and a half years after passage of the BPCIA. And on January 7, 2015 the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of Novartis/Sandoz’ investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the referenced product’s (Amgen’s NEUPOGEN®) label.
As the U.S. catches up with the EU regarding biosimilars (the European Medicine Agency has approved 19 biosimilars to be marketed in the EU) it will need to address key concerns from various groups including innovator companies, generic companies, regulatory groups, state and federal governments, payers, healthcare providers and patient advocates.
On January 6, the FDA released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity.
Topics covered include: what data will be allowed for demonstrating biosimilarity, labeling requirements for biosimilars, and how interchangeability will be determined.
The titles of the forthcoming biosimilarity guidances will be as follows:
- Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
- Considerations in Demonstrating Interchangeability to a Reference Product
- Labeling for Biosimilar Biological Products
- Statistical Approaches to Evaluation of Analytical Simialrity Data to Support a Demonstration of Biosimilarity
The full 2015 CDER Guidance Agenda may be read here. This blog will keep up to date with these important publications.
There are numerous advocates for biosimilars in the U.S. One of the most organized voices is the Alliance for Safe Biologics. The ASBM is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Among their key members: The Biotechnology Industry Organization (BIO), Amgen, and Genentech. ASBM is working hard to frame policies for a fertile biosimilars environment in the U.S.
State governments are also working diligently to ensure access to new biosimilars by sponsoring legislation allowing pharmacists, under very specific circumstances, to substitute biosimilars for prescribed reference biologics.
According to the National Conference of State Legislatures, following is a tally of states that have made progress:
- Eight states have enacted statutes.
- One state (California) passed a bill through both chambers; it was vetoed by the governor.
- 14 other states had bills filed, which are pending or did not pass as of session adjournments.
We will continue to keep track of the progress being made at the state level here.