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  • Posted by: InterbrandHealth on Monday, June 11 2012 04:28 PM | Comments (0)
    Wes Wilkes

    The true market potential for biosimilars has been under a microscope. In our last blog post we framed the industry, looking at some of the varying and conflicting points of view of major players in the industry. In this post we will begin exploring InterbrandHealth’s perspective on biosimilars.

    We recently participated in the Financial Times US Healthcare and Life Sciences Conference on June 6, 2012 in New York City. Below are some of the points that were discussed during the biosimilars panel that Wes Wilkes, our Executive Director of Global Strategy, participated in during the panel Biosimilars: Coming of Age?

    Biosimilars are here. Most of the conversation today is how the regulatory pathways will shape the landscape in the US, EU, and the rest of the world. What we are helping most of our clients with today is looking past the regulatory approvals and focusing on the uptake and competition post-regulatory approval.

    The uptake in developed markets will ultimately provide significant savings and access to a new population of patients. But new entrants may be underestimating the loyalties that exist with reference product manufacturers, and the trepidation that may exist for providers and patients to switch to the biogenerics, specifically those that treat more chronic conditions.

    We are not talking the same price disparities we see with generics in the small molecule space. In some markets we may be talking less than 30% in price savings, not to mention the price elasticity reference product manufacturers are willing to explore as the basement price for many of the big products is still unknown. Pair that with the brand loyalty, trust and safety that have been built up over the last decade — and we have a much different game on our hands.

    Some of the newer entrants can learn from the mistakes made in the past in the small molecule space, especially in how they will compete and differentiate themselves in a highly competitive environment.We see the future successors differentiating themselves on:

    1) The corporate/manufacturer brand

    2) The manufacturing process

    3) The technologies and delivery devices

    However, we see most of the efforts to date being placed in the reverse order. Of course the technology and delivery device is an obvious differentiator, but we are encouraging our clients to consider the uptake barriers that do and will exist post-approval.

    One of the greatest barriers is concern over safety and quality controls. Yes, the price will be a driver of choice, but the hurdle of a relatively “unknown” player with different manufacturing technologies may not be enough to overcome the price disparity.

    Starting now to lay the foundation of the corporate and manufacturer equities will be key to post-approval commercial success. Providers and payers will have an increased scrutiny on this space especially in the more chronic conditions. We feel that focusing only on the differences in delivery and dosing may be a bit myopic in a category where brand loyalty, trust and respect will be key.

    Stay tuned for a white paper on biosimilars where we will be exploring these commercial strategies in more depth. For more information on this topic please email: info@interbrandhealth.com

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  • Posted by: InterbrandHealth on Wednesday, May 30 2012 05:55 PM | Comments (0)

    DNA

    Photo Credit: Shutterstock

    Biosimilars have been in the news recently as testimony has been offered to the FDA on the subject and excitement mounts as some see significant growth opportunities for the pharmaceutical and generic industries. The Financial Times' US Healthcare and Life Sciences Conference is bringing together an international line-up of industry experts, government decision-makers and leading market commentators to explore the market potential for Biosimilars. InterbrandHealth's Executive Director of Global Strategy Wes Wilkes is a confirmed panel speaker on this significant subject.

    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.

    Next week we will continue our blog series on Biosimilars with a post exploring the role that Brand plays in the Biosimilars market.

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