It's complicated. Those words sum up the current status and apparent future of biosimilars.
It's complicated. Those words sum up the current status and apparent future of biosimilars, which received a boost from the Patient Protection and Affordable Care Act and its amendment of the Public Health Service Act of 2009.
In brief, the legislation establishes:
The path to biosimilar approval
Incomplete agreement and layers of complexity
"Right now, legislation is high level, but it should become more specific regarding requirements by the end of the year. There is not complete agreement on what biologics are, and now we are adding another layer of complexity with biosimilars," Sherman said.
Without a standard definition of a biologic, Sherman said, products with biological components may be approved through either drug or biologic licensure pathways.
For example, the FDA approved an abbreviated new drug application (ANDA) for generic enoxaparin (low-molecular-weight heparin) in 2010, while the European Medicines Agency (EMA) considers low-molecular-weight heparins to be biologics and requires a more robust approval.
Another concern is just how much research will be necessary to establish similarity, since a biosimilar is not an exact replica of an innovator product.
Pharmacists Play Unique Role in Advancing Health Equity for Patients With Chronic Disease
December 7th 2023A new study, outlined in a poster at ASHP Midyear 2023, identified 3 key themes associated with the ways in which pharmacists are positioned to advance health equity for patients with chronic diseases.
Assessing Financial Impacts of Pharmacist-Led Interventions in Pediatric Ambulatory Care
December 5th 2023According to a poster abstract presented at the ASHP Midyear Clinical Meeting & Exhibition, specialty pharmacy services were used for a variety of conditions that have been reported in adult populations.