Biopharmaceuticals & Biosimilars

BiopharmaceuticalsThe commercial use of biologics (biopharmaceuticals), which began a few decades ago with the introduction of recombinant human insulin, has revolutionized modern medicine and the industry expects that it will continue to do so.

2010 global biologics sales totaled more than USD 100 billion, and steadily growing demand for these cutting-edge medicines means that annual growth rates are several times those of the overall pharmaceutical sector. By 2016, the figure is expected to reach USD 150 billion or higher - with many leading drugs no longer protected by patents

 

What They Are

Biologics are medicines produced from living organisms using commercial biotechnology techniques. They are far more complex than "traditional" small-molecule, chemically-synthesized molecules. For example, even a simple biologic such as calcitonin has a molecular weight of nearly 3500 daltons compared to just 180 daltons for aspirin - while a complex monoclonal antibody clocks in at 150 000 daltons. Biologics therefore represent a distinct regulatory class of medicine.

Many biologics are recombinant proteins, which can be produced at commercial scale in a number of ways including "recombinant DNA" (inserting a specific gene into a host cell to produce a particular protein) or mammalian cell culture technologies. These methods are highly sophisticated and resource-intensive, requiring dedicated production lines and specialist training; quality standards are also exceptionally high.

Developing and manufacturing a biologic typically involves a four-stage process:

  • Modify host cells (e.g., bacteria, yeast) to produce recombinant proteins
  • Grow the cells under controlled conditions (fermentation)
  • Extract, refold, and purify (downstream) to generate the drug substance
  • Formulate to create a stable finished drug product (vial, syringe, cartridge)

Why They Matter

As the global population continues to grow and to age, biologics are increasingly being recognized as the only medicines capable of effectively treating complex diseases including cancer and autoimmune disorders. Their unique ability to bind to specific targets within the body contributes significantly to improved survival rates, enhanced longevity, and better quality of life.

As a result, the global market is growing at least twice as fast as that for standard pharmaceuticals, with biologics currently representing approximately 15% of total pharmaceutical sales and nearly a third of the global development pipeline. By 2016, it is estimated that seven of the top 10 pharmaceuticals worldwide will be biologics, including five monoclonal antibodies (targeted protein-based therapeutics).

Biosimilars

A biosimilar, or follow-on biologic, is a successor to a biologic medicine that has lost patent protection or exclusivity. Due to their relative complexity, something they share with all biologic drugs, biosimilars represent a separate regulatory class of medicines to small-molecule generics.

Biosimilars are biologics, and are approved via stringently defined regulatory pathways on the basis that they have demonstrated comparability (high similarity) to their reference product. To win approval, they need to demonstrate both a highly analogous structure (via robust analytical characterization) and comparable quality, safety, and efficacy (via appropriate clinical trials).

Biosimilars can be approved in the same indications as the reference product provided that the mechanism of action is equivalent for all indications. They are recognized around the world as safe and effective medicines. "Alternative biologics", follow-on versions of existing products that have been approved in local markets but not according to stringent regulatory pathways in highly regulated markets, are - by definition - not biosimilars.

Biosimilar development requires substantial time and investment. A typical biosimilar takes 7-8 years to develop, at a cost of between USD 75 and 250 million, with clinical trials that may involve about 500 patients.

That compares to 8-10 years for a new drug application, at a cost of USD 800 million, including up to 1000 patients in clinical trials. For a small-molecule generic, by comparison, development may be completed in 2-3 years, at a cost of USD 2-3 million.

Biosimilars - Market Challenges

Biosimilars still face a number of challenges across geographies, in particular:

  • The uncertain regulatory and legal environment in many countries and regions
  • Significant development investment requirements in terms of time, resources, and expertise
  • The need to access cost efficient and high quality manufacturing capacity and expertise
  • The complex commercial environment, with stakeholders including competitors, regulators, payors, physicians, pharmacists, and patient groups
  • Powerful originator competition

 

We at YES Pharma are committed to leading the way in years and decades to come, and to doing our bit to transform medications in the modern healthcare industry.

Please do not hesitate to contact us for any of your requirements for Biopharmaceuticals & Biosimilars at info@yespharma.com

We look forward to hearing from you !

Dun and Bradstreet