Editorial

  1. 4 Conversations Integral To Building Biosimilar Partnerships
    6/19/2018

    Thanks to Mundipharma's Richard Trollope, I not only got the inside scoop on what makes a biosimilar partnership specifically a biosimilar partnership, but also Mundipharma’s journey in launching Remsima, Truxima, and, most recently, Herzuma.

  2. How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access
    6/19/2018

    Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?

  3. Critique Of Literature Review Highlights Areas For Future Study And Education
    6/12/2018

    A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.

  4. Market Access Impediments: Where Should Biosimilars Go From Here?
    6/12/2018

    Biosimilars were touted as a payer’s tool to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million).

  5. Considering A Future In Biosimilars: The Small Biotech Perspective
    6/7/2018

    A small biotech company faces specific challenges when navigating both the biosimilar and the innovative space. I wanted to get a better sense of how smaller companies originally defined as biosimilar pure-plays, like Pfenex, are ensuring longevity in the biosimilars space.

  6. Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility
    6/4/2018

    I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.

  7. Cross-Sector Intelligence: The Prospects For Data Convergence In Biopharma
    6/1/2018

    This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.

  8. Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know
    5/22/2018

    The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.

  9. Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities
    5/18/2018

    While Amgen’s report shares payers’ broad considerations about biosimilars and the impact they’d have, Avalere’s report digs more deeply into the available data from payers to show just how biosimilars are stacking up. And, frankly speaking, I found some of the information quite concerning.

  10. How To Win Over U.S. Payers On Biosimilars
    5/15/2018

    Payers are widely considered the gatekeepers to the U.S. market for biosimilars. If you can address their specific concerns related to price, contract terms, evidence, FDA designation, and other factors, they will eagerly grant you access to patient populations who are yet to reap the benefits of biosimilars. Easy, right?