The Financial Times describes the current atmosphere, promise and controversy around Biosimilars and topics for discussion within the panel, “The emerging market for Biosimilars is expected to represent an important growth opportunity for pharma and generic companies in the years ahead. Regulatory pathways for Biosimilars are already well established in Europe, where the focus is moving to more complex biological products, and the FDA is in the process of establishing a framework. Opinion is split, however, on the true real potential of this market, with some suggesting that the market will grow to a multi-billion dollar market in the next 5 years, while others point to the slower development of Biosimilar products in Europe, as well as regulatory and cost challenges to show that Biosimilars will never be a serious threat to branded pharmaceuticals.”
Doug Trapp of American Medical News explained Biosimilars in a piece on the FDA’s release of a draft proposal in February to give a detailed explanation of approval requirements. “Biologics includes a variety of vaccines, blood and blood components, gene therapies, tissues and proteins, according to the FDA guidance. Biologics are made using complex, large molecules and typically are significantly more difficult to manufacture than small molecule drugs, such as aspirin. A Biosimilar is a product based on an original biologic that has no meaningful clinical differences from the original.”
In 2010 the FDA reported the Biologics Price Competition and Innovation Act (BPCI Act) amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products demonstrated to be Biosimilar with an FDA licensed product. The Immune Deficiency Foundation’s (IDF) President and Founder Marcia Boyle testified before the FDA this month, urging the agency to exempt immunoglobulin (Ig) therapies from the Biosimilars pathways of drug approvals. Boyle argued the FDA should follow the example of the European Medicines Agency to exempt Ig therapy from Biosimilars pathway or to require Biosimilar products to undergo clinical trials to determine if clinical outcomes are the same with proposed interchangeable therapies.
While opinions differ on the potential of the Biosimilars market, Zachary Russ in a recent article in Genetic Engineering and Biotech News argues, “…the EMA is properly handling the question of how to evaluate Biosimilars.” But he raises a number of questions.
Russ asks, “An assay technologies and expression systems continue to improve, will we ever see two different manufacturers with different processes make identical Biologics? Can the Biosimilar approval model be used for approving Biologics with intentionally different kinetics? What level of similarity is worth pursuing? In the event that a biologic finds a new indication, how will the approval of that indication for approved Biosimilars be handled?”
The Biosimilars: Coming of Age? panel at the Financial Times Healthcare Conference will explore the true market potential for Biosimilars — the drivers and resistors to future growth. And InterbrandHealth’s Wes Wilkes is an avid thought leader and speaker on the changing role of brand within the healthcare sector, including the rapidly developing markets. The Financial Times US Healthcare and Life Sciences Conference will be held at The University Club, New York City June 6, 2012 and Biosimilars: Coming of Age? will be from 4:30pm – 5:30pm.