Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama’s Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation. Members from the agency’s biologics and drug evaluation and research centers (CDER and CBER), as well as the Office of Compliance, will be on the panel. The new legislation allows for follow-on biologics, also referred to as biosimilars and biogenerics depending on who you are talking to, to be developed after 12 years of patent exclusivity.
According to FDA’s hearing announcement in the Oct. 5, 2010 Federal Register, the agency wishes to obtain input on the following overarching topics: biosimilarity; interchangeability; patient safety and pharmacovigilance; the use of supportive data and information; definition of a biological product; the need for guidance; exclusivity; transition provisions; and user fees. More specifics are outlined in the Register.
The full lineup of presenters representing industry and other healthcare organizations is listed here. Representatives of the trade associations, PhRMA, BIO, and GPhA, are each presenting this afternoon. These three groups support the follow-on biologics pathway in general but have different ideas about its implementation.
PhRMA, for example, is being represented by Marie Vodicka, PhD, PhRMA Science and Regulatory Affairs. Vodicka gave a presentation on the topic in 2009, and according to that presentation, PhRMA believes that certain concepts will allow for safe and effective follow-on biologics. These concepts include: adequate quality; adequate pre-clinical and clinical testing requirements; and appropriate use.
BIO also has a set of key principles it stands by when it comes to follow-on biologics, which include the following, listed on the organization’s online fact sheet: ensure patient safety; recognize scientific differences between drugs and biologics; maintain the physician-patient relationship; preserve Incentives for Innovation; ensure transparent statutory and regulatory processes; continue to prioritize FDA preview and approval of new therapies and cures.
GPhA has the following statement on its website about follow-on biologics: “By every account, competition from biogenerics in the biologic sector would save patients, insurers and the government billions of dollars each year in treatment costs. Estimates from various economic impact studies pin the projected savings from $42 billion on the low end to as high as $108 billion over the first 10 years of biogeneric market formation. Even stakeholders on the brand side of this issue—namely BIO and PhRMA—recognize that biogeneric competition will significantly reduce health care costs.”
The hearing is being broadcast from FDA headquarters and can be watched at these urls:
-Day 1 (Nov 2): https://collaboration.fda.gov/part15day1/
-Day 2 (Nov 3): https://collaboration.fda.gov/part15day2/
The transcript of the hearing will be available here.
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