6 Public Policy Changes To Ensure A Competitive Biosimilar Market
6 Public Policy Changes To Ensure A Competitive Biosimilar Market

Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.

  • Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?
    Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?

    How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.

  • Why You Should Engage With Regulatory Early In Product Development
    Why You Should Engage With Regulatory Early In Product Development

    The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.

  • Beyond Pricing: Can Biosimilars Compete On Value?
    Beyond Pricing: Can Biosimilars Compete On Value?

    In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.

  • AmerisourceBergen: Responsible Pricing, Patient Programs Biggest Biosimilar Challenges
    AmerisourceBergen: Responsible Pricing, Patient Programs Biggest Biosimilar Challenges

    In the first part of this two-part article, we touched on the two strategies for distributing biosimilars. In this article, Lozano highlights some of the common topics that pose the greatest challenges for manufacturers, in particular pricing their products and establishing patient and provider services. 

  • 2018 CBI Biosimilars Summit Unveils New Industry Focus Areas
    2018 CBI Biosimilars Summit Unveils New Industry Focus Areas

    As more real-world evidence demonstrating biosimilars’ efficacy and safety is released, I daresay I speak for many in the U.S. who are left asking, “What more do we need?” Well, this event turned me on to a few areas that could use some work and renewed attention.

  • 4 Keys To Bridging The Biosimilar Gap: Transforming Awareness Into Prescribing Action
    4 Keys To Bridging The Biosimilar Gap: Transforming Awareness Into Prescribing Action

    In the past two years, nine biosimilars have been approved by the FDA, three for use in cancer patients and six for use in patients with inflammatory arthritis and inflammatory bowel diseases.

  • The Wholesaler’s Guide To Biosimilar Distribution
    The Wholesaler’s Guide To Biosimilar Distribution

    It’s rare that I should stumble upon an article discussing how biosimilars actually end up at the hospital or pharmacy in the first place. So I took the opportunity to speak with AmerisourceBergen's Richard Lozano to get a better sense of the manufacturer-wholesaler relationship and some of the questions companies must consider as they prepare to supply their biosimilars to the market.

  • Should Pharma Companies Even Care About Brexit?
    Should Pharma Companies Even Care About Brexit?

    Brexit — and the looming fear of it — appeared on a number of pharmaceutical industry recap articles and columns for 2017, as well as ones looking forward into 2018, with many describing it as the most important factor affecting the industry in the next few years. As with all trends, someone will choose to swim against the tide and make the argument against conventional reasoning.

  • How Will The CVS/Aetna Merger Impact Biosimilars?
    How Will The CVS/Aetna Merger Impact Biosimilars?

    Mergers and acquisitions (M&As) are commonplace across the healthcare landscape. Such consolidation is intended to drive efficiencies and spur growth. Traditionally, such M&A activity has involved horizontal integration — the marriage of similar types of organizations (i.e., a pharmaceutical company and a biotech; a national insurance provider with a regional player). The desired merger of CVS and Aetna, however, introduces a dramatically different dynamic — the vertical integration of two different types of businesses, a pharmacy/drug distribution entity and an insurance company, to create a new type of healthcare system. How will such a new entity impact biosimilar use?

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