Biosimilar Development solution center

1. Africa’s Biosimilar Landscape: Outlook & Current Challenges 6/2/2020

   Emerging markets, particularly Africa, represent an interesting case study for biosimilars. With a young population of more than 1.3 billion, Africa’s economy is the world's second-fastest growing, and the GDP is expected to grow to 3.9 percent in 2020 and 4.1 percent in 2021, according to the African Development Bank.

2. “Show Me The Data:” New Publication Moves Long-Held Regulatory Debate Forward 5/27/2020

   A new peer-reviewed paper, armed with the necessary data, aims to carry us into the days of more tailored biosimilar development. Lead author Martin Schiestl discusses the paper’s most important findings and what implications these data will have for biosimilar developers and regulators.

3. Biosimilar Clinical Trials: Past, Present, And (Near) Future 5/20/2020

   As we continue discussing the role of large comparative efficacy studies in the biosimilar development paradigm, two Covance experts focus more specifically on the near-term clinical challenges companies are likely to face as the biosimilar pipeline diversifies in the next few years.

4. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

   This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

5. Samsung Bioepis CEO: A COVID-19 Call To Action 5/14/2020

   There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.

6. The Pharmacist’s Role In Biosimilar Uptake: The Art Of Formulary Management 5/12/2020

   Unless we’re pharmacists ourselves, we rarely get a look into the formulary-building process and what this can mean for biosimilar usage overall. Here, pharmacist Sophia Humphreys of Providence St. Joseph Health shares the ins-and-outs of formulary building and the role pharmacists can play to encourage greater biosimilar usage. 

7. Crowded Biosimilar Clinical Trial Landscape Requires Differentiation 5/6/2020

   At the U.S. World Biosimilar Congress, Covance's Joan Meyer highlighted the biggest clinical trial challenges and shared tips on how biosimilar companies can communicate the benefits of comparative efficacy trials for patients and investigators alike.

8. Approaches To Improve Efficiency In Biopharmaceutical Process Development 5/5/2020

   Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. These tools make process development more efficient.

9. Is Not Using A CDMO Slowing Down Your Process Development? 4/27/2020

   Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

10. Insulin Under The BPCIA: Opportunities And Obstacles 4/22/2020

    As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.