understanding biosimilars

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Biosimilars Markets Well Established

The market estimates based on current sales highly underestimate the future markets, still biosimilars present one of best business model, as the generic pharma is steadily decilining.


Biosimilars constitute a multi billion dollar industry and a dire need for patients. Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensing pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. The largest source of teaching about biosimilar drugs is created by the founder of KBL, Dr. Sarfaraz K. Niazi; click here or onto the image below to access these books.

The FDA Perspective

FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. The FDA provides teachings of every subject related to biosimilars and here are links to these topics:

What Is a Biosimilar?

The Promise of Biosimilars

The Basics of Biosimilars

The Concept of Interchangeability

The Biosimilar Development Process

Biosimilar Development Process (Infographics)

Analytical Data for Biosimilar Products

Biological Product Definitions

Biosimilar Product Regulatory Review and Approval

Prescribing Biosimilar Products

Industry Information and Guidance

Online Courses, Webinars, and Presentations

Patient and Prescriber Outreach Materials

Fully integrated model

All competitors of KBL are fully integrated, a model that requires large capital investment and longest time, and above all, regardless of the investment, ends up with a bottle-neck limiting the number of biosimilars that can be developed and produced. KBL has disrupted this model.

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Fully outsourced model

The KBL model requires no capital investment, no regulatory compliance risks, no molecule-specific expertise constraint and above all, no limit on number of products developed simultaneously. KBL sponsoring partners can now be marketing affiliates with no manufacturing infrastructure.

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