Biosimilar Clinical Development: The Complete Solution


Advance Your Biosimilar Development With the Experts

Novum’s experienced global team of scientists, physicians, and respected CRO industry professionals will collaborate with your team to develop a pathway for your biosimilar clinical product development programs.


Biosimilars are Becoming a Key Sector of the Global Pharmaceutical Market

  • 88.5% of prescriptions filled are for unbranded generic drugs
    • Biosimilars are gaining traction and will continue to grow in market share
    • Since 2006:
      • US – 35 biosimilars approved by FDA
      • EU – 55 biosimilars approved by EMA
  • The Biosimilar Market is expected to reach $88.12 billion by 2030, rising for $13 billion in 2021
    • This 21.3% CAGR is expected due to rising tumor cases worldwide, increasing R&D investment, and the cost-effectiveness of biosimilar drugs
    • The number of patients suffering from different types of cancers is rising significantly each year worldwide. Molecular profiling and other advanced diagnostic techniques are changing the way many cancers are identified and treated. The past decade has seen a shift in the concept of cancer therapy. New immunotherapy medications target immune cells, thereby inducing the immune system to eradicate tumor cells. Because of molecular profiling, biologics can offer personalized treatment that often improves clinical outcomes, extends survival, and restores patients’ quality of life in a way that chemotherapy cannot. However, these medications can be expensive, thus creating a barrier to their access. Biosimilar medication is increasingly available to reduce this barrier, and this drives market growth
    • Lower price biosimilars may also help save costs for the healthcare system. According to estimates, $250 billion may be saved between 2014 and 2024 in the US if 11 biosimilars were to enter the market. Biosimilars could potentially play an important role in increasing patient access to biologic therapies, which is expected to drive the market revenue growth.
  • Amgen, Biogen, Celltrion, Merck & Co Inc, Patheon, Pfizer, Sandoz, Viatris, and many other pharmaceutical producers are active within the biosimilar market


Lets Get Your Project Started

Lets Get Your Project Started



The Biosimilar Development Pathway

With the rapidly increasing prevalence of biosimilars entering the market, it is important to work with an expert team that understands the development pathway.

This pathway can be challenging due to:

  • Competition to be ‘first to file’ or otherwise achieve early market entry makes meeting timelines critical
  • Indications (oncology, autoimmune) require large patient populations challenging enrolment timelines and budgets
  • Biosimilars are often difficult to enroll in highly developed nations e.g., US, Western Europe, creating Rest of World competition for patient populations.
  • Regulations between EU and US not yet fully harmonized; and other major regulatory venues are carving out their own regulatory pathways (e.g., China)


biosimilar approval pathway


Project Stalled? Lets Get Your Project Back on Track

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Novum’s Biosimilar Solutions Expertise

Biosimilars will provide greater numbers of patients around the world with life-saving medicines at affordable prices. At Novum, our team has supported biosimilar advancements since their inception.


The Novum Team Has:

  • Manufactured preclinical and clinical biosimilars
  • Developed and validated unique assays for biosimilar products
  • Designed and executed global biosimilar clinical development plans
  • Assisted sponsors with achieving biosimilar product approvals across the globe


Follow this link for more information – Biosimilars in Clinical Trials


The Novum Advantage

  • Growing pipeline of biosimilar projects for global sponsors
  • Experience spanning the entire range of biologics development from 1993 and biosimilars from 2006
  • Experienced Project Management & Clinical Team tailored to your specific biosimilar project
  • Able to identify and design/execute programs to meet regional, national, and global regulatory requirements
  • We are committed to supporting lowering patient costs through biosimilars
  • We offer complete clinical solutions from Phase I through Phase III


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