1. 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.

  2. An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations

    Analytical instrument can provide a high level of confidence in the integrity and quality of the manufactured product through scientific data, and that confidence can only be achieved through proper instrument qualification

  3. Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain

    According to the latest PharmSource Trend Report, "Bio/Pharma CapEx Trends 2016", biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain.

  4. Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

    There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.