FDA hosts hearing on biologics issues

Agency seeks input on implementation of Biologics Price Competition and Innovation (BPCI) Act

Amy Swinderman
SILVER SPRING, Md.—As many large pharmas begin to launch major initiatives focused on biologics development, the U.S. Food and Drug Administration (FDA) has scheduled a two-day public hearing this month to receive input on the Biologics Price Competition and Innovation (BPCI) Act of 2009, a statute establishing an abbreviated pathway for biological products that are biosimilar or interchangeable with an FDA-licensed product.

Facing a steep patent cliff and sluggish pipelines, Big Pharma has been making a push to explore biologics as a potential area of growth. Recently, many top pharmas have made acquisitions or signed partnership deals with companies doing work in this area: Merck & Co. Inc.'s acquisition of Abmaxis and Insmed's follow-on biologic business, Pfizer Inc.'s acquisition of Rinat Neuroscience and AstraZeneca PLC's purchase of MedImmune and Cambridge Antibody Technology, to name a few.

According to Evaluate Pharma, biologics could top pharma sales by 2014. The firm predicts that half of the top 100 drugs in 2014 will be biotech meds, a huge change from last year's level of 28 percent and 11 percent in 2000.

However, the FDA has yet to put into place regulations for the approval of generic versions of biological product.

The hearings, held Nov. 2-3 at the FDA's White Oak Campus in Silver Spring, Md., gave interested stakeholders the chance to provide input regarding the FDA's implementation of the statute. Expected to appear are interested members of the public, healthcare professionals, healthcare institutions, manufacturers of biomedical products, industry and professional associations, patients and patient associations, third-party payers and current and prospective biological license application and new drug application holders.

The BPCI Act is a subtitle of the Patient Protection and Affordable Care Act signed into law by President Barack Obama on March 23. The statute's objectives are conceptually similar to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, which established abbreviated pathways for the approval of drug products under the Federal Food, Drug and Cosmetic (FD&C) Act. The FDA says the BPCI Act aligns with the agency's "longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing."

"The implementation of an abbreviated approval pathway for biological products can present challenges given the scientific and technical complexities that may be associated with the larger and often more complex structure of biological products, as well as the processes by which such products are manufactured," the FDA says.

Most biological products are produced in a living system such as a microorganism, or plant or animal cells, whereas small-molecule drugs are typically manufactured through chemical synthesis. According to the BPCI Act, a biological product may be demonstrated to be "biosimilar" to a biological reference product based on data derived from analytical studies, animal studies and a clinical study—notwithstanding minor differences in clinically inactive components, and if there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency.

In addition, the statute prescribes that in order to meet the higher standard of "interchangeability," a product must demonstrate that it can produce the same clinical result as the reference product in any given patient. If the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product must not be greater than the risk of using the reference product without such alternation or switch.

The BPCI Act's more contentious provisions prescribe a 12-year period of marketing exclusivity from the date of first licensure of the reference product, during which approval of a 351(k) application referencing that product cannot be made effective. These provisions include an exclusivity period for the first biological product submitted in a 351(k) application that has been determined to be interchangeable with the reference product for any condition of use, during which a second or subsequent biological product may not be determined interchangeable to that reference product, as well as a transition provision for protein products that have been or will be approved under Section 505 of the FD&C Act.

The FDA says it is particularly interested in obtaining comment on biosimilarity; interchangeability; patient safety and pharmacovigilance; the use of supportive data and information; the definition of "biological product"; guidances; exclusivity; transition provisions; and user fees.

Updates on the hearing will be available on ddn's Web site, www.drugdiscoverynews.com, as well as our blog, http://ddnonline.wordpress.com/.


Amy Swinderman

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